Last updated: 2025-05-01

83 Quality Engineering jobs in Boston.

Hiring now: Asset Lead @ Pfizer, Regulatory Cmc Spec @ Orchard Th, Dir Quality Management Sy @ Formation , Associate Dir Development @ Astrazenec, Sr Validation Engr @ Cai, Cmms Data Spec @ Cushman Wa, Sr Proj Validation Engr @ Project Fa, Svp Of Regulatory And Qua @ Ascidian T, Prod Mgr Cms Regulatory S @ Pa Consult, Program Leader Medtech Qu @ Veeva Syst.Explore more at jobswithgpt.com.

🔥 Skills

project management (17) compliance (13) GMP (13) regulatory compliance (12) cGMP (11) Quality Assurance (10) continuous improvement (9) collaboration (9) cross-functional collaboration (8) Risk Management (7)

📍 Locations

Boston (26) Cambridge (24) Waltham (8) Lexington (5) Chelmsford (4) Peabody (3) Somerville (2) Watertown (2) Woburn (2) North Andover (1)
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Pfizer

Asset Lead North Andover
Skills & Focus: asset lifecycle management, QC instruments, cGMP compliance, instrument validation, capital planning, project management, cross-functional collaboration, quality procedures, data integrity, continuous improvement
About the Company: Pfizer is a multinational pharmaceutical corporation engaged in the development of pharmaceuticals and vaccines.
Experience: 2 years with a bachelor's degree, 0+ years with a master's degree, 6 years with an associate's degree, or 8 years with a high school diploma.
Salary: $80,300.00 to $133,900.00
Type: Full-time
Benefits: 401(k) plan, paid vacation, personal days, caregiver/parental and medical leave, health benefits.

Orchard Therapeutics

Regulatory CMC Specialist Boston
Skills & Focus: regulatory, CMC, gene therapy, biologics, ATMP, documentation, compliance, submission, collaboration, product lifecycle
About the Company: Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the develop…
Experience: Minimum 3 years of regulatory CMC experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs).
Type: Full-time

Formation Bio

Director, Quality Management Systems Boston
Skills & Focus: pharmaceutical quality systems, QMS, regulatory compliance, cGMP, quality assurance, internal and external audits, corrective and preventive actions, cross-functional collaboration, quality metrics, leadership
About the Company: Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. The company partners, acquires, or in-license…
Experience: 12+ years
Salary: $210,000 - $300,000
Type: Full-time
Benefits: Equity, generous perks, hybrid flexibility, comprehensive benefits.

Astrazeneca

Associate Director, Development Asset Quality Boston
Skills & Focus: Quality Assurance, Good Clinical Practice, Compliance, Risk Management, Clinical Trials, Investigation, Inspection Readiness, Continuous Improvement, Data Quality, Regulatory Inspections
About the Company: AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.
Experience: Minimum of 8+ years of experience in clinical research area
Type: Full-time

Cai

Senior Validation Engineer Boston
Skills & Focus: Commissioning, Qualification, Validation, pharmaceutical manufacturing, protocol writing, troubleshooting, documentation, project management, regulatory compliance, team coordination
About the Company: CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation,…
Experience: 4-12 years
Salary: $102,100 - $111,700 a year
Type: Full-time
Benefits: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to empl…

Cushman & Wakefield

CMMS Data Specialist Boston
Skills & Focus: CMMS, asset management, preventive maintenance, calibration, data management, GMP regulations, process improvement, engineering, reporting, data accuracy
About the Company: C&W Services is an Equal Opportunity employer to all protected groups, including protected veterans and individuals with disabilities. Discrimination of any ty…
Salary: $40hr
Type: Full-time

Project Farma

Senior Project / Validation Engineer Boston
Skills & Focus: validation, project management, engineering, quality/compliance, teamwork, problem-solving, GxP best practices, technical documents, manufacturing processes, cross-functional collaboration
About the Company: Project Farma is the leading advanced therapy technical operations consulting company in the life science industry.
Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
Salary: $50,000 - $240,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective fir…

Ascidian Therapeutics

SVP of Regulatory and Quality Boston
Skills & Focus: regulatory strategy, quality assurance, compliance, regulatory filings, INDs, BLAs, NDA, GMP, GCP, risk management
About the Company: Ascidian is redefining the treatment of disease by rewriting RNA. Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. In our…
Experience: 15+ years
Benefits: We offer a generous total rewards plan that includes competitive compensation, stock options, and benefits, including a…

Pa Consulting

Product Manager - CMS Regulatory Specialist Boston
Skills & Focus: Product Management, CMS Regulations, Software Development, Product Ownership, Healthcare Quality Measurement, Regulatory Compliance, Product Development, Cross-functional Collaboration, Client Interaction, Quality Improvement
About the Company: PA Consulting is a leading provider of managed software services for healthcare quality measurement and reporting, dedicated to improving healthcare outcomes t…

Veeva Systems

Program Leader - MedTech Quality Boston
Skills & Focus: Vault Quality implementation, MedTech, Quality, Manufacturing technology, Account Management, Professional Services, Customer Success, program management, continuous improvement, life sciences industry
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: Experienced program leader
Type: Full-time
Benefits: Flexible work from home or in the office

Nchroma Bio

Director/Sr. Director, Quality Assurance Boston
Skills & Focus: Quality Assurance, GxP, cGMP, GCP, GLP, Quality Management Systems, regulatory processes, cross-functional teams, continuous improvement, biotech startup
About the Company: nChroma Bio is a pioneering biotechnology company redefining the future of in vivo targeted genetic medicine to treat a wide array of diseases and bring cures …
Experience: Minimum of 10 years GMP QA management experience in the Biotech/Pharmaceutical industry
Type: Full-time

Alexion

Associate Director, Development Asset Quality Boston
Skills & Focus: Quality Culture, GCP, Clinical Trials, Risk Management, Compliance, Quality Assurance, Inspections, Regulatory, Data Analysis, Continuous Improvement
About the Company: To transform the lives of people affected by rare diseases and devastating conditions by continuously innovating and creating meaningful value in all that we d…
Experience: Minimum of 8+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance.

Formation Bio

Senior Director, GMP QA Boston
Skills & Focus: GMP QA, cGMP compliance, quality assurance, clinical trials, audits, performance monitoring, AI technologies, quality management, regulatory requirements, pharmaceutical industry
About the Company: Formation Bio is a tech and AI-driven pharma company differentiated by radically more efficient drug development. Founded in 2016, it focuses on accelerating a…
Experience: 15+ years in quality assurance roles within the pharmaceutical industry
Salary: $260,000 - $370,000 (NYC/Boston) / $235,000 - $335,000 (Remote)
Type: Full-time
Benefits: Equity, generous perks, hybrid flexibility, and comprehensive benefits.

Pa Consulting

Product Manager - CMS Regulatory Specialist Boston
Skills & Focus: Product Owner, software development, product vision, regulatory compliance, healthcare quality measurement, client interaction, cross-functional teams, product backlog, CMS regulations, training and support
About the Company: PA Consulting is a leading provider of managed software services for healthcare quality measurement and reporting, dedicated to improving healthcare outcomes t…

Seaport Therapeutics

Associate Director, Quality Assurance - CMC Boston
Skills & Focus: GMP, quality assurance, clinical development, compliance, regulatory requirements, pharmaceutical, biotechnology, cGMP, project management, quality metrics
About the Company: Seaport Therapeutics is seeking an experienced Associate Director, QA CMC to manage GMP quality assurance activities supporting clinical development programs, …
Experience: 8 – 10 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related function

Cushman & Wakefield

GxP Automation Technician Boston
Skills & Focus: BMS, EMS, Automation Systems, GxP, Maintenance, Operational Proficiency, Safety Compliance, Troubleshooting, Preventive Maintenance, Project Coordination
About the Company: C&W Services provides facilities services within Cushman & Wakefield, focused on facility operations and management.
Type: Full-time

Eight Sleep

Health Products Lead Boston
Skills & Focus: health business, regulatory pathways, reimbursement pathways, program management, product development, FDA clearance, medical product, cross-functional program, hardware, software
About the Company: Eight Sleep is the world’s first sleep fitness company committed to fueling human potential through optimal sleep. Utilizing innovative technology, detailed de…
Experience: 6+ years of industry experience in medical devices (hardware or SaMD)
Type: Full-time
Benefits: Health, vision, and dental insurance, supplemental life insurance, flexible PTO, commuter benefits, paid parental leave…

Whoop

Regulatory Affairs Specialist Boston
Skills & Focus: Regulatory Affairs, Quality Systems, QMS, strategy, support, health, performance, problem-solving, dynamic, agile
About the Company: WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives.

Veeva Systems

Quality Engineer Boston
Skills & Focus: Quality Engineer, Vault Infrastructure, SaaS platform, life sciences, pharmaceuticals, biotechnology, medical devices, infrastructure modules, collaboration, fast-paced setting
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: Graduate or about to graduate
Type: Full-time
Benefits: Flexibility to work from home or in the office, collaborative environment, dedicated buddy support during onboarding.

Project Farma

Project Engineer Boston
Skills & Focus: biomanufacturing, Project Management, cell and gene therapy, pharmaceutical, validation, quality compliance, technical delivery, engineering, supply chain, patient focused
About the Company: Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy a…
Experience: 0-3 years of consulting and/or project engineer experience
Salary: Competitive salary based on experience
Type: Full-time
Benefits: Aggressive bonus structure, Medical, Dental, and Vision insurance effective your first day of employment, 401k Plan wit…

Quera Computing, Inc.

Laser Systems Engineer - Quantum Systems Boston
Skills & Focus: laser systems, quantum computing, optical engineering, R&D, cross-functional collaboration, system integration, laser technologies, safety regulations, productization, high-precision
About the Company: QuEra Computing is pioneering the future of quantum computing technology.
Experience: Ph.D. in Optical Engineering, Physics, Electrical Engineering, or a related field. Exceptional candidates with a Master's degree and significant experience will also be considered.

Kura Oncology

Director, Clinical Systems Boston
Skills & Focus: Clinical Operations, IT, biopharmaceutical, computer system validation, GxP, regulatory compliance, project management, stakeholder engagement, risk-based approach, system integrations
About the Company: Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of blood cancers and solid t…
Experience: 10+ years’ experience in Clinical Operations, IT, or related function in a biopharmaceutical setting.
Type: Full-time
Benefits: Career advancement/development opportunities, competitive comp package, bonus, 401K with employer contributions, genero…

Astrazeneca

Director, Device Development - Parenterals Drug Delivery Devices Boston
Skills & Focus: device development, parenterals, combination product, engineering principles, design controls, risk management, regulations, cross-functional, technology selection, product development
About the Company: AstraZeneca is one of the world’s most forward-thinking and connected BioPharmaceutical companies, committed to delivering life-changing medicines.
Experience: 15 years of related experience
Type: Full-time

Ketryx

Customer Success Associate Boston
Skills & Focus: customer success, client operations, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, quality
About the Company: Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secu…
Experience: Minimum of 1 year professional experience (internships included) in the SaaS industry.
Salary: $65,000 - $90,000
Type: Full-time
Benefits: Competitive compensation, generous stock options possible, hybrid work model, generous PTO for full-time employees.

Whoop

Quality Systems & Regulatory Affairs Manager (Medical Devices) Boston
Skills & Focus: Quality Systems, Regulatory Affairs, Medical Devices, Regulatory Submissions, Quality Management System, Post-market Processes, Compliance, Product Development, Consumer Wearable, Problem-solving
About the Company: WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.

Pa Health Data Platforms

Quality Assurance Engineer Boston
Skills & Focus: Quality Assurance, Engineer, software development, maintenance, cloud-based systems, clinical data, biopharmaceutical, highest quality standards, data platforms, medical spectrum
About the Company: The PA Health Data Platforms team is dedicated to building data platforms for the clinical and biopharmaceutical community to change the course of care across …

Astrazeneca

Senior Human Factors Engineer Boston
Skills & Focus: human factors engineering, medical device, combination product, usability studies, ethnography, risk analysis, product development, cross-functional collaboration, device development, design controls
About the Company: AstraZeneca is one of the world’s most forward-thinking and connected BioPharmaceutical companies, focused on delivering life-changing medicines.
Experience: Bachelor’s Degree and 10+ years of related experience and/or 3+ years of experience in applying human factors engineering to medical device or combination product development -OR- Master’s Degree and 8+ years of related experience and/or 3+ years of experience in applying human factors engineering to medical device or combination product development.
Salary: $104,270 - $156,405
Type: Full-time
Benefits: Qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; health benefits including medical,…

Johnson & Johnson

Senior Analyst, Records Management Brockton
Skills & Focus: Records Management, Quality Systems, Compliance, Regulatory requirements, Process Improvement, Cost Reduction, Metrics Development, Training Materials, Quality Events, Automation
About the Company: Johnson & Johnson believes health is everything, empowering healthcare innovation to prevent, treat, and cure complex diseases.
Experience: 4-6 years’ experience in Records Management or actively handling Quality or Manufacturing records in a regulated industry, preferably GMP and/or ISO.
Type: Hybrid

Siphox Health

Senior Mechanical Design Engineer Burlington
Skills & Focus: mechanical designs, medical devices, diagnostic devices, injection molding, automated assembly, rapid prototyping, engineering tests, 3D modeling, cross-functional teams, ISO 13485
About the Company: SiPhox, supported by Y Combinator, Intel, and Khosla Ventures, is revolutionizing diagnostics through silicon photonics. Our in-vitro diagnostic (IVD) devices,…
Experience: 3+ years
Type: Full-time

Amgen

Specialist IS Business Systems Analyst Cambridge
Skills & Focus: CDS applications, GxP validation, systems analysis, machine learning, Agile methodologies, software engineering, quality assurance, cloud services, technology compliance, platform innovation
About the Company: At Amgen, we are relentless in applying the highest ethical standards to our products, services and communications. Our shared mission—to serve patients living…
Experience: Doctorate degree OR Master’s degree and 2 years of systems analysis experience Or Bachelor’s degree and 4 years of systems analysis experience Or Associate’s degree and 8 years of systems analysis experience Or High school diploma / GED and 10 years of systems analysis experience
Salary: 115058.00 USD - 143472.00 USD
Type: Full time
Benefits: Our award-winning culture is collaborative, innovative, and science-based. We offer a range of benefits including healt…

Novartis

Biomedical Research Submission Management, Associate Director Cambridge
Skills & Focus: regulatory submissions, submission management, cross-functional teams, NDA, MAA, submission planning, project management, quality standards, critical path activities, continuous improvement
About the Company: Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare profess…
Type: Hybrid

Biogen

Manager, ICSR Processes and Systems Cambridge
Skills & Focus: ICSR, compliance, regulatory requirements, Biogen, procedural document updates, training material updates, change management, system testing, GxP, problem solving

Blueprint Medicines

Director of Environmental Health & Safety (EH&S) Cambridge
Skills & Focus: Environmental Health & Safety, EH&S programs, biopharma, safety protocols, regulatory compliance, employee safety, hazardous materials, incident preparedness, culture of continuous improvement, industry certification
About the Company: Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines, focusing on allergy/inflammation and oncology…
Experience: 10+ years of EH&S experience, with focus on building strong EH&S culture and leading teams to EH&S excellence.
Type: Full-time
Associate Director, Medical Writing Cambridge
Skills & Focus: medical writing, regulatory submissions, clinical data, cross-functional collaboration, document management, project management, regulatory compliance, Common Technical Document, quality control, standard operating procedures
About the Company: Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solvi…
Experience: 7+ years of experience in medical/clinical/regulatory writing in the pharmaceutical/biotechnology/healthcare industry; 3+ years of regulatory document project management oversight/experience

Regeneron Pharmaceuticals Inc.

Manufacturing Specialist I Cambridge
Skills & Focus: cell therapy, clinical manufacturing, process operations, documentation, compliance, batch production records, clean rooms, SOPs, cGMP, collaboration
About the Company: Regeneron is a biotechnology company that discovers, develops, and manufactures innovative medicines for the treatment of serious diseases.
Experience: HS diploma and 6+ years or a Bachelor’s degree and 2+ years of relevant experience.
Salary: $38.03 - $62.07/hour
Type: Contract
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, paid time off.

Amgen

Senior Engineer, Combination Products - Process Engineering Cambridge
Skills & Focus: process engineering, drug delivery, device manufacturing, failure investigations, design control, technical records, project management, collaboration, manufacturing processes, combination products
About the Company: At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all…
Experience: 10 years of Engineering and/or Operations experience
Salary: 119,195.00 USD - 147,867.00 USD
Type: Full time
Benefits: Competitive benefits and collaborative culture
Assoc. Director of Engineering – Platform Technical Lead: Mechanical Autoinject… Cambridge
Skills & Focus: engineering, device development, project management, regulatory compliance, manufacturing, testing, technical documentation, supplier management, quality standards, autoinjector devices
About the Company: At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all…
Salary: 176,070.00 USD - 208,816.00 USD
Type: Full time

Aditum Bio

VP of CMC Cambridge
Skills & Focus: CMC operations, drug substance, drug product manufacturing, cGMP, Phase 3 registration, regulatory submissions, Contract Manufacturing Organizations, supply chain, clinical studies, FDA regulations
About the Company: At Aditum Bio our mission is to provide access to medicines to patients in need. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark F…
Experience: Minimum 10 years in pharmaceutical/biotechnology industry
Salary: $345,000 to $375,000 plus target bonus, equity compensation
Type: Full-time
Benefits: Medical, dental, vision, disability, life, 401k plan with match, flexible/non-accrued PTO plus 12 paid holidays, sick l…

Scholar Rock

Director, CMC Outsourcing Drug Product Cambridge
Skills & Focus: biologics, drug product, manufacturing, GMP, CDMO, quality standards, contracts, technical documents, regulatory filings, supply chain
About the Company: Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unme…
Experience: Minimum 10 years of relevant experience in biologics contract manufacturing management.
Type: Full-Time

Amgen

Senior Sterilization Engineer Cambridge
Skills & Focus: Sterilization, Biotechnology, Healthcare, Gas sterilization, Process validation, Regulatory compliance, Collaboration, Technical lead, Quality assurance, Project management
About the Company: Amgen is a pioneer in the world of biotech, dedicated to serving patients living with serious illnesses. With a focus on oncology, inflammation, general medici…
Experience: 4+ years of Engineering experience
Salary: 119,195.00 USD - 147,867.00 USD
Type: Full-time

Biogen

Senior Engineer II Cambridge
Skills & Focus: drug delivery devices, product design, combination products, regulatory compliance, regulatory filings, engineering, manufacturability, experimental plans, design optimization, cross-functional collaboration
About the Company: Biogen is a pioneer in developing innovative drug delivery devices for patient-centric solutions.
Experience: Minimum 6 years of experience in product design.
Salary: $103,000-$165,000
Type: Hybrid
Benefits: Medical, Dental, Vision, & Life insurance; Fitness & Wellness programs; On-site childcare; Short- and Long-Term Disabil…

Cullinan Therapeutics, Inc.

Senior Manager/Associate Director, Quality Management Systems Cambridge
Skills & Focus: quality management systems, cGxP regulatory standards, continuous improvement, collaboration, business needs, technology leverage, solution management, compliance, process streamlining, clinical-stage assets
About the Company: Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built…

Astrazeneca

Engineer II, Downstream Development, Viral Vector Product Development Cambridge
Skills & Focus: downstream development, viral vector purification, AAV manufacturing, experiments, tech-transfer, analytical data, process optimization, chromatography, filtration, documentation
About the Company: AstraZeneca is committed to making a difference by following the science to explore and innovate. We work towards treating, preventing, modifying, and even cur…
Experience: 3+ years (BS) or 0 years (MS) experience in the biotech industry, including internships or co-op experience
Salary: $87,000 to $130,000
Type: Full-time
Benefits: qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; health benefits including medical,…

Biogen

Manager, R&D Document Control Management Cambridge
Skills & Focus: document control, technical writing, policies, standard operating procedures, quality, compliance, audits, inspections, process documents, collaboration

Beam

Regulatory co-op Cambridge
Skills & Focus: Regulatory Affairs, regulatory intelligence, guidance documents, data verification, submissions, Quality Control, methodology, biotechnology, bioengineering, team player
Experience: Prior industry internship or academic lab-based research experience is preferred
Type: Co-op
Benefits: Hybrid (partially remote, partially onsite) working environment
Co-op in CMC (Chemistry Manufacturing and Controls) / External Manufacturing Cambridge
Skills & Focus: CMC, Chemistry Manufacturing, Controls, data analysis, KPI, metrics, project management, cross functional teams, SharePoint, Microsoft Project
Experience: Pursuing a technical degree in Science or Engineering, with an interest in project management
Type: Co-op

Syner-G Biopharma Group

Facilities Technician IV Cambridge
Skills & Focus: Facilities Technician, HVAC, maintenance, FDA-regulated, cGxP, building systems, wastewater management, preventative maintenance, technical expertise, regulatory strategy
About the Company: Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences c…
Experience: 7-10 years of experience in a scientific discipline, or equivalent work experience.
Salary: $45 to $50
Type: Full-time
Benefits: Excellent healthcare options including medical, vision, prescription & dental, parental leave, flexible time-off, 401(k…

Beam Therapeutics

Director or Senior Director, Clinical Data Management Cambridge
Skills & Focus: Clinical Data Management, CDM, CRO, Regulatory Compliance, GCP, EDC Systems, CDASH/CDISC Standards, Clinical Trials, Data Quality Management, Team Collaboration
About the Company: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines, with a focus on …
Experience: 15+ years of experience in clinical data management, including 14 years in the pharmaceutical or CRO with experience managing Phase I, II and III studies.

Azenta Life Sciences

CSS Senior Technician Cambridge
Skills & Focus: bio sample management, SOPs, inventory tracking, GMP, safety requirements, chain of custody, audit trails, preventative maintenance, customer service, continuous process improvement
About the Company: Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We provide automa…
Experience: Bachelor’s Degree + 6 months demonstrated proficiency in sample management, OR Associate Degree + 2 years, OR HS Diploma + 4 years
Type: Full-time

Blueprint Medicines

Manager, Investigational Supply Operations Cambridge
Skills & Focus: clinical supply plans, CTM packaging, labeling, distribution, inventory management, GMP, CROs, project management, forecasting, Good Clinical Practices (GCP)
About the Company: Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solvi…
Experience: 3 years in the management of CTM packaging and labelling, including CTM for international studies, preferably within the pharmaceutical or biotechnology industry
Type: Full-time

Biogen

Principal Engineer, Technical Lead Cambridge
Skills & Focus: device development, drug delivery systems, regulatory compliance, medical devices, engineering, project management, combination products, design for manufacturing, innovation, cross-functional collaboration
About the Company: Biogen is a biotechnology company specializing in the development of innovative therapies for neurological diseases.
Experience: 10+ years in medical device design, especially drug delivery systems.
Salary: $156,000-$215,000
Type: Hybrid
Benefits: Medical, Dental, Vision, & Life insurance, Fitness & Wellness programs, on-site childcare, Disability insurance, paid v…

Flagship Labs 112, Inc. (Fl112)

Manufacturing and Formulation Scientist Cambridge
Skills & Focus: biomanufacturing, formulation development, scaling processes, microbial formulations, advanced characterization techniques, spray drying, lyophilization, process optimization, collaborative workflows, GMP compliance
About the Company: FL112 is revolutionizing sustainable water solutions by harnessing cutting-edge science to address global water scarcity. The company is well-funded and operat…
Experience: 4-6+ years of industry experience in biomanufacturing, formulation development, or process development, including highly relevant post-doc experience.

Regeneron Pharmaceuticals

Senior Validation Specialist- Computer System Validation Cambridge
Skills & Focus: Computer System Validation, FDA compliance, GMP, validation documentation, risk assessments, collaboration, quality compliance, validation protocols, change controls, GxP-regulated systems
About the Company: Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Our culture promotes an inclusive envir…
Experience: 5+ years of relevant work experience
Salary: $82,600.00 - $134,800.00
Type: Contract
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Teleflex

Quality Engineer II, Design Assurance Chelmsford
Skills & Focus: Quality Improvement, Manufacturing, Regulatory Affairs, Risk Management, Test Method Development, Process Validation, Statistical Techniques, Documentation, Root Cause Analysis, Supplier Process Improvement
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. We offer a diverse portfol…
Experience: 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).
Type: Contract
Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: Design Assurance, New Product Development, Test Method Development, Regulatory Affairs, Risk Management, Design Verification, Validation, Data Analysis, Quality System, Collaboration
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to beco…
Experience: Two years of related experience required.
Sr. Regulatory Affairs Specialist Chelmsford
Skills & Focus: Regulatory Affairs, medical devices, submissions, premarket notifications, EU MDR, risk management, compliance, project deliverables, audits, team collaboration
About the Company: Teleflex is a global provider of medical technologies dedicated to improving the health and quality of people's lives. It offers diverse medical solutions in a…
Experience: 5+ years of Medical Device Regulatory Affairs experience
Type: Contract
Benefits: Eligible for benefits during contract period

Staples, Inc.

Product Quality and Safety Specialist Framingham
Skills & Focus: Product Quality, Safety, Regulatory Compliance, Risk Management, Quality Assurance, Consumer Expectations, Data Analysis, Documentation, Cross-functional Teams, Continuous Improvement
About the Company: Staples is business to business. Our merchandising team aims to deliver the best value and selection to our customers through products, services and solutions …
Experience: 3+ years of experience in Product quality assurance, product safety, quality engineering, or a related field.
Type: On-site
Benefits: Flexible PTO (22 days), Holiday Schedule (7 observed paid holidays), Online and Retail Discounts, Company Match 401(k),…

Genezen

Manufacturing Associate Lexington
Skills & Focus: gene therapy, GMP, manufacturing operations, cGMP, cell culture, purification, SOP, production equipment, safety compliance, continuous improvement
About the Company: Genezen is focused on providing process development, producing GMP viral vectors, and providing cell transduction for gene and cell therapy clinical trials.
Experience: 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in Life Sciences/Engineering.
Type: Full-time
Benefits: Paid vacation days, paid sick time, 401(k) plan with company match, health care plans, FSA and HSA programs, dental & v…
Manufacturing Associate Lexington
Skills & Focus: GMP, viral vectors, cGMP, SOPs, Cell Culture, Purification, Batch Production Records, troubleshooting, manufacturing operations, aseptic techniques
About the Company: We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials.
Experience: 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
Type: Full-time
Benefits: Paid vacation days, paid sick time, 401(k) plan with company match, share appreciation rights, healthcare plans, dental…
Quality Assurance Specialist II Lexington
Skills & Focus: Quality Management System, GMP, cGMP, deviations, Corrective and Preventive Actions (CAPAs), investigations, change controls, batch record review, data integrity, biologics/gene therapy
About the Company: The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral v…
Experience: 3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Benefits: Paid vacation days, paid sick time, 10 observed holidays + 2 floating holiday + 1 volunteer day, 401(k) plan with compa…

Sbm Management Services, Lp

GMP Coordinator Lexington
Skills & Focus: GMP, project coordination, safety certifications, client communication, training, cleaning procedures, compliance, investigations, logbooks, CMMS
Experience: 6mo to 1 year of experience – preferred
Salary: $29.00 - $30.00 per hour

Rapid Micro Biosystems

Manufacturing Engineer Lowell
Skills & Focus: manufacturing, engineering, cGMP, design transfer, problem-solving, equipment validation, statistical tools, process documentation, collaborative team, quality improvement
About the Company: Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in th…
Experience: 3+ years of manufacturing/process engineering experience required.
Type: Full-time

Teleflex Incorporated

Engineer I, Components Mansfield
Skills & Focus: engineering projects, manufacturing activities, regulatory compliance, process development, design control, quality assurance, customer communication, continuous improvement, project management, medical device
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to beco…
Experience: 0-3 years of experience in medical device, regulated industry, or related field.

Johnson & Johnson

Senior Analyst, Records Management Peabody
Skills & Focus: Records Management, Quality Systems, Compliance, Regulatory requirements, Process Improvement, Cost Reduction, Metrics Development, Training Materials, Quality Events, Automation
About the Company: Johnson & Johnson believes health is everything, empowering healthcare innovation to prevent, treat, and cure complex diseases.
Experience: 4-6 years’ experience in Records Management or actively handling Quality or Manufacturing records in a regulated industry, preferably GMP and/or ISO.
Type: Hybrid
Design Quality Engineer Co-op - Emerging Tech Peabody
Skills & Focus: Design Quality, Engineer, Co-op, MedTech, quality engineering, design verification, validation activities, risk management, new product development, critical to quality
About the Company: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,…
Experience: Enrolled in an accredited College/University, completion of sophomore year by Spring 2025.
Salary: $22 - $51.50 per hour
Type: Intern/Co-Op
Benefits: Eligible for medical insurance, sick time, holiday pay, housing stipend, and the Company’s consolidated retirement plan.
Sr. Equipment Engineer - 2nd Shift Peabody
Skills & Focus: Equipment Engineering, Preventative Maintenance, Calibration, Good Manufacturing Practices, Validation, Troubleshooting, Production Manufacturing, Technical Support, Continuous Improvement, Medical Devices
About the Company: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,…
Experience: Minimum of 5 years of experience in equipment engineering, preferably in the medical device manufacturing industry.
Salary: $105,000-$169,050
Type: Full-time
Benefits: Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insu…

Tessera Therapeutics

Lead, Oligonucleotide CMC Somerville
Skills & Focus: Oligonucleotide synthesis, Scale-up, Purification process, GMP requirements, CMC sections, IND filings, Regulatory filings, Analytical characterization, External manufacturing, Cross-functional development
About the Company: Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeu…
Experience: PhD + 4 or M.S. + 6 years of experience in the biopharmaceutical industry
Type: Full-time
Benefits: Group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuiti…
Senior Manager, Clinical Supply Chain Somerville
Skills & Focus: clinical supply chain, biotechnology, clinical labeling, packaging, distribution, clinical trial material, vendor management, GMP, global regulatory compliance, Gene Editing
About the Company: Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeu…
Experience: 12+ years of clinical supply chain experience or Master's degree with 10+ years of experience.
Type: Full-time
Benefits: competitive package of base and incentive compensation, comprehensive benefits program including group medical, vision …

Ardelyx

QA Computer Systems Specialist Waltham
Skills & Focus: Quality Assurance, GxP computer systems, validation, risk assessments, regulatory requirements, FDA compliance, project management, SOPs, data integrity, enterprise system applications
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 5+ years of experience in a Quality environment or equivalent experience
Salary: $112,000-$136,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marr…
Executive Director, GCP, GLP and GVP Quality Waltham
Skills & Focus: Quality Assurance, GCP, GLP, Pharmacovigilance, QA systems, risk management, regulatory compliance, audit programs, regulatory inspections, continuous improvement
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 15+ years related experience, preferably in life sciences with 8+ years in GCP/GLP Quality and PV Quality
Salary: $269,000-$329,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks paid parental leave, living organ and bone marrow leave, equity ince…
QA Computer Systems Specialist Waltham
Skills & Focus: Quality Assurance, GxP computer systems, validation, audit, risk assessment, regulatory requirements, SOPs, policy implementation, project management, data integrity
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 5+ years of experience in a Quality environment or equivalent experience
Salary: $112,000-$136,000
Type: Full-time
Benefits: Ardelyx offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks o…

Dentsply Sirona, Inc

R&D Manager Waltham
Skills & Focus: Product Development, Medical Device, 3D CAD, Regulatory Documentation, Design Control, Project Management, Collaboration, Sustaining Engineering, Manufacturing, Innovation
About the Company: Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the …
Experience: 10 years professional experience with at least 5 years in precision medical device product development
Type: Hybrid

Invivyd

Associate Director, Clinical Quality Assurance and Compliance Waltham
Skills & Focus: Clinical Quality Assurance, Compliance, GCP, GLP, Regulatory, Clinical Development, Quality Systems, Audit, Training, Pharma/Biotech
About the Company: At Invivyd, Inc., we are dedicated to delivering protection from serious viral infectious diseases, starting with COVID-19. We leverage a proprietary integrate…
Experience: A minimum of 6 years relevant GCP experience in pharma/biotech company
Type: Full-time

Dyne Therapeutics

Manager, Quality Control Waltham
Skills & Focus: GMP, QC testing, stability management, analytical development, quality systems, regulatory submissions, data analysis, CROs, collaboration, communication
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leve…
Experience: 4-6 years’ experience in GMP QC testing and/or QC stability management
Senior Manager, Clinical Supply Waltham
Skills & Focus: clinical supply, inventory management, drug development, compliance, project management, contract manufacturing, GxP, IVRS, CRO, deviations
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leve…
Experience: Minimum of 5 years of related experience in the pharmaceutical industry with at least 3 years of direct experience in Global Clinical Supply Management.

Ardelyx

Executive Director, GCP, GLP and GVP Quality Waltham
Skills & Focus: Quality Assurance, GCP, GLP, PV, Risk Management, Regulatory Compliance, Audit Programs, Inspections, Clinical Development, Continuous Improvement
About the Company: Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medic…
Experience: 15+ years related experience, preferably in life sciences with 8+ years in GCP/GLP Quality and PV Quality
Salary: $269,000-$329,000
Type: Full-time
Benefits: 401(k) plan with generous employer match, 12 weeks paid parental leave, up to 12 weeks living organ and bone marrow lea…

Landmark Bio

QC Microbiology Analyst II Watertown
Skills & Focus: Microbiology, Environmental Monitoring, Bioburden, Endotoxin, Sterility, Growth Promotion, cGMP, Documentation, Quality control, Team-oriented
About the Company: Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-…
Experience: 3+ years of experience working in a QC Microbiology lab/ GMP cleanroom environment
Type: Full-time
Senior Specialist, Quality Assurance Operations Watertown
Skills & Focus: Quality Assurance, GMP, cell therapy, manufacturing, documentation, compliance, batch records, investigations, continuous improvement, performance objectives
About the Company: Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-…
Experience: 6-8 years in a biotechnology manufacturing environment
Type: Full-time

L3harris Technologies

Space Program, Quality Engineering Wilmington
Skills & Focus: Quality Engineer, space-based imaging systems, program quality plan, inspection, testing, compliance, nonconformities, Material Review Board, PFMEA, project management
About the Company: L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedicati…
Experience: Bachelor’s Degree and minimum 4 years of prior relevant experience.
Type: Full-time

Sirtex

Senior Regulatory Affairs Specialist Woburn
Skills & Focus: regulatory submissions, FDA, license renewals, registration, compliance, quality system, advertising, clinical trial, regulatory assessments, post-market compliance

Perkinelmer

Principal Systems Engineer Woburn
Skills & Focus: Systems Engineering, risk management, regulatory compliance, project leadership, biotechnology, medical devices, FDA, quality control, collaboration, data analysis
About the Company: Covaris, LLC (a PerkinElmer subsidiary) is a leading sample preparation solution provider in Biotechnology headquartered in Woburn, Massachusetts and has pione…
Experience: 8+ years of engineering experience, 5+ of Systems Engineering.
Type: Full Time

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