74 Quality Assurance And Engineering jobs in Boston.

Hiring now: Compliance Dir Advanced W @ Smithnephe, Cms Regulatory Spec @ Pa Consult, Gxp Lead Automation Tech @ Cushman Wa, Proj Engr @ Precision , Svp Of Regulatory And Qua @ Ascidian T, Program Leader Medtech Qu @ Veeva Syst, Regulatory Affairs Spec @ Whoop, Proj Engr @ Precision , Sr Mgr Us Medical Review @ Alexion, Customer Success Associat @ Ketryx.Explore more at jobswithgpt.com.

🔥 Skills

project management (10) regulatory compliance (10) GMP (9) compliance (8) continuous improvement (8) Quality Assurance (8) cross-functional collaboration (7) Medical Device (6) engineering (6) quality assurance (6)

đź“Ť Locations

Cambridge (33) Boston (29) Chelmsford (4) Lexington (4) Burlington (2) North Andover (1) Marlborough (1)
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Smith+Nephew

Compliance Director, Advanced Wound Management North Andover
Skills & Focus: Compliance, Advanced Wound Management, Medical Device, Pharmaceutical, Risk Assessment, Regulatory, Monitoring, Training, Auditing, Project Management
About the Company: Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
Experience: 7+ years of experience related to implementing a compliance programme in USA.
Benefits: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement, Flexible Personal/Vacation T…

Pa Consulting

CMS Regulatory Specialist Boston
Skills & Focus: Product Owner, software development, product vision, regulatory standards, compliance, cross-functional teams, CMS regulations, product backlog, customer support, healthcare quality measurement
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…
Experience: Strong background in Product Management, experience in product ownership within a software development environment

Cushman & Wakefield

GxP Lead Automation Technician Boston
Skills & Focus: BMS, EMS, GxP, automation systems, maintenance, health and safety, training, collaboration, engineering, communication
About the Company: Cushman & Wakefield is a global leader in commercial real estate services and investment, providing innovative solutions to clients.
Type: Full-time

Precision For Medicine

Project Engineer Boston
Skills & Focus: Project Engineer, Consulting, Engineering life cycle, Technical documents, System validation, GxP best practices, Problem-solving skills, Patient Focused, People First, Cross-functional collaboration
About the Company: Precision for Medicine, Manufacturing Solutions is a leading advanced therapy technical operations consulting company in the life science industry, committed t…
Experience: A minimum of 1 year of Project Engineer, Consulting, and/or relevant industry experience
Salary: $66,000 - $82,500 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…

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

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.

Precision For Medicine, Manufacturing Solutions

Project Engineer Boston
Skills & Focus: Project Engineer, Consulting, Life Science, Engineering, Validation, Manufacturing, Quality, Supply Chain, Technical Documents, GxP Best Practices
About the Company: Leading advanced therapy technical operations consulting company in the life science industry.
Experience: Minimum of 1 year of Project Engineer, Consulting, and/or relevant industry experience.
Salary: $66,000 — $82,500 USD
Type: Full-time
Benefits: Competitive salary, Aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan, Paid Time Off, Compan…

Alexion

Senior Manager, US Medical Review Boston
Skills & Focus: medical review, pharmaceutical, biotech, communications, regulations, pharmacovigilance, promotional materials, training, therapeutic area, medical education
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: 3 years of medical information or medical communications experience in the pharmaceutical/biotech industry.
Salary: $113,821.60 - $170,732.40
Type: Full-time
Benefits: 401(k) plan; paid vacation and holidays; paid leaves; health benefits including medical, prescription drug, dental, and…

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.

Veeva Systems

Senior Consultant - Veeva Vault Quality Boston
Skills & Focus: consultant, cloud-based technology, SaaS, quality management, lifesciences, customer relationships, agile delivery, release management, data management, implementation
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: 8+ years of experience in IT Project Management, GMP Systems ownership, or Software Consulting
Salary: $80,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

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…

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

Precision For Medicine, Manufacturing Solutions

Technical Operations Consultant Boston
Skills & Focus: manufacturing, life science, engineering, project management, validation, quality/compliance, technical documents, GxP best practices, problem-solving skills, Patient Focused
About the Company: Precision for Medicine, Manufacturing Solutions is the leading advanced therapy technical operations consulting company in the life science industry, committed…
Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience
Salary: $67,100 – $70,150 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective you…

Veeva Systems

Global Program Manager - Quality Boston
Skills & Focus: program management, software delivery, Life Sciences, Healthcare, Quality Vault, implementation programs, customer success, project execution, strategic relationships, GxP technology
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: 12+ years in large-scale program management with software delivery in the Life Sciences or Healthcare sectors
Salary: $100,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

Formation Bio

Director, Medical Writing Boston
Skills & Focus: medical writing, clinical development, regulatory documents, pharmacovigilance, cross-functional teams, AI tools, Good Clinical Practice, document author, stylish guidelines, continuous improvement
About the Company: Formation Bio is a tech and AI driven pharma company focused on radically more efficient drug development, utilizing technology platforms and AI advancements t…
Experience: 7+ years in the development of clinical and regulatory documents
Salary: $250,000 - $300,000 for NYC and Boston; $238,000 - $285,000 for other eligible remote locations
Type: Hybrid
Benefits: Equity, generous perks, hybrid flexibility, comprehensive benefits
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.

Precision For Medicine, Manufacturing Solutions

CQV Engineering Consultant Boston
Skills & Focus: CQV Engineering, life science, project management, validation life cycle, patient centered, team mentoring, technical documentation, client engagement, business development, regulatory compliance
About the Company: We are the leading advanced therapy technical operations consulting company in the life science industry. As a Patient Focused, People First delivery team, we …
Experience: A minimum of 3 years of Project Engineer, Consulting, and/or relevant industry 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 you…

Veeva Systems

Global Program Manager - MedTech Quality Boston
Skills & Focus: program management, Quality Vault implementations, customer success, strategic oversight, governance, IT relationships, executive communication, large programs, technology strategy, GxP implementations
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: 12+ years in large-scale program management with software delivery in the Life Sciences or Healthcare sectors
Salary: $100,000 - $200,000
Type: Full-time
Benefits: Medical, dental, vision, basic life insurance, Flexible PTO, company paid holidays, Retirement programs, 1% charitable …

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,…

Tango Therapeutics

Pharmacovigilance Operations Lead Boston
Skills & Focus: Pharmacovigilance, regulatory submissions, safety data, PV processes, TMF documentation, vendor performance, FDA regulations, EMA regulations, life sciences, ARGUS
About the Company: Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the trea…
Experience: At least 3 – 5 years’ experience in PV Operations

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.

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

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

Boston Scientific

Clinical Database Analyst III Boston
Skills & Focus: Clinical Data, eCRF Design, Data Management, Collaboration, Medical Device, Data Integrity, Validation, Technical Design, Good Clinical Practices, User Acceptance Testing
About the Company: Boston Scientific is a leader in medical science for more than 40 years, committed to solving the challenges that matter most, united by a deep caring for huma…
Experience: Minimum 2 years of Clinical Database (eCRF) Design experience
Salary: $76,000 - $144,400
Type: Hybrid
Benefits: Competitive core and optional employee benefits

Cushman & Wakefield

GxP Lead Automation Technician Boston
Skills & Focus: Automation, BMS, EMS, GxP, OSHA, Maintenance, Engineering, Facilities, Quality, Pharmaceutical
Type: Full-time

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…

Eurofins

Director of Consulting Services Boston
Skills & Focus: consulting, medical device, regulatory compliance, quality assurance, strategic leadership, client management, pre-clinical, clinical support, market access, risk assessments

Boston Scientific

Clinical Database Analyst III Burlington
Skills & Focus: Clinical Data, eCRF Design, Data Management, Collaboration, Medical Device, Data Integrity, Validation, Technical Design, Good Clinical Practices, User Acceptance Testing
About the Company: Boston Scientific is a leader in medical science for more than 40 years, committed to solving the challenges that matter most, united by a deep caring for huma…
Experience: Minimum 2 years of Clinical Database (eCRF) Design experience
Salary: $76,000 - $144,400
Type: Hybrid
Benefits: Competitive core and optional employee benefits

Lightforce Orthodontics

Regulatory Affairs and Compliance Manager Burlington
Skills & Focus: regulatory affairs, compliance, medical devices, FDA, quality compliance, regulatory strategies, transparency reporting, cross-functional collaboration, ISO 13485, analytical skills
About the Company: LightForce Orthodontics is a technology company focused on a new era of personalized orthodontics that launched the world's only fully customized digital brack…
Experience: 5+ years
Type: Part-time

Biogen

Director, CMC Asset Lead - Neurodegeneration Cambridge
Skills & Focus: CMC, Asset Strategy, Cross-functional Leadership, Neurodegeneration, Project Management, Drug Development, Supply Chain, Risk Mitigation, Strategic Planning, Biopharmaceutical
About the Company: Biogen is a pioneer in biotechnology, focused on transforming the lives of people living with serious neurological diseases.
Experience: At least 12 years of relevant experience; Advanced degree preferred in a biopharmaceutical discipline.
Salary: $200,000-$275,000
Type: Full-time
Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, paid vacation, sick time, holidays, 401(k) wit…

Amgen

Senior Engineer, Design Transfer Specialist Cambridge
Skills & Focus: design transfer, medical devices, manufacturing processes, regulatory requirements, engineering testing, vendor management, process validation, continuous improvement, CAD, quality management
About the Company: At Amgen, we pioneer the world of biotech in our fight against the world’s toughest diseases, focusing on oncology, inflammation, general medicine, and rare di…
Experience: 4 years of Engineering experience with a Bachelor's degree, or 2 years with a Master's degree, or equivalent 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…
Director of Global Reg CMC for Combination Products and Medical Devices Cambridge
Skills & Focus: regulatory strategy, combination products, medical devices, global regulatory affairs, team leadership, compliance, regulatory submissions, health authorities, cross-functional collaboration, medical device regulations
About the Company: Biogen is a biotechnology company that develops therapies for neurological diseases.
Experience: A minimum of 12 years in Medical Device and Combination Products with at least 8 years in Global Regulatory Affairs.
Salary: $175,000-$219,000
Type: Full-time
Benefits: Full range of benefits including medical, dental, vision insurances, paid vacation, holiday time off, and more.

Blueprint Medicines

Manager, PV Validation Cambridge
Skills & Focus: pharmacovigilance, compliance, quality assurance, database systems, SQL, project management, user acceptance testing, incident management, regulations, continuous improvement
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: Master’s degree in computer science, Industrial Engineering, or a closely related field (or foreign equivalent degree), plus 2 years of experience in database systems QA.

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…

Astrazeneca

Engineer II, Downstream Development, Viral Vector Product Development Cambridge
Skills & Focus: downstream development, AAV manufacturing, purification techniques, analytical data, experiments, tech transfer, biological materials, documentation, collaboration, technical documents
About the Company: AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, par…
Experience: 3+ years (BS) or 0 years (MS) experience in the biotech industry, including internships or co-op experience
Salary: $87,000 - $130,000
Type: Full-time
Benefits: Short-term incentive bonus, equity-based long-term incentive program, 401(k) plan, paid vacation and holidays, health b…

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

Astrazeneca's Alexion Division

Principal Scientist, External Viral Vector Testing Cambridge
Skills & Focus: Quality Control, AAV Products, Regulatory Standards, Quality Assurance, Biopharmaceuticals, Analytical Development, Risk Identification, Process Development, Contract Manufacturing, Technical Documentation
About the Company: AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wi…
Experience: PhD in biochemistry, biological science, chemistry, or chemical engineering (or related fields) with 4+ years of relevant experience, or BS/MS with 8+ years of experience in biopharmaceutical organization with expertise in quality control, analytical development, and/or tech transfer
Type: Full-time

Bicycle Therapeutics

Quality Control and Validation Manager Cambridge
Skills & Focus: Quality Control, Validation, Microbiology, Aseptic, GMP, Regulatory, Document Review, Stability Protocols, Environmental Monitoring, Compliance
About the Company: Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are…
Experience: Experienced QC microbiology requirements for aseptic manufacturing
Type: Full-time, Contract
Benefits: Flexible working environment, Competitive reward including annual company bonus, Employee recognition schemes, 28 days …

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…

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

Boston Scientific

Principal Regulatory Affairs Specialist Cambridge
Skills & Focus: Regulatory Affairs, FDA, EU, medical devices, regulatory submissions, PMA, 510(k), international regulatory, compliance, technical documentation
About the Company: Boston Scientific Corporation has been a leader in medical science for more than 40 years, committed to solving the challenges that matter most, united by a de…
Experience: Minimum of 7 years of Regulatory Affairs experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
Salary: $99,100 - $188,300
Type: Hybrid
Benefits: Core and optional employee benefits vary based on location and other pertinent factors.

Amgen

Engineer - Risk Management, Combination Product Operations Risk Engineering (CP… Cambridge
Skills & Focus: risk management, combination products, medical devices, risk assessments, design controls, regulatory requirements, continuous improvement, hazard analyses, US Quality System Regulations, ISO 14971
About the Company: Amgen focuses on serving patients living with serious illnesses and has been a pioneer in the field of biotechnology since 1980.
Experience: 2 years of risk management, engineering, and/or medical device experience with a Bachelor's degree preferable.
Salary: 93,344.00 USD - 107,268.00 USD
Type: Full time
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

Bicycle Therapeutics

Associate Director Clinical Quality Cambridge
Skills & Focus: Quality Assurance, GCP, clinical trials, regulatory compliance, audits, quality management, development programs, safety processes, flexibility, team collaboration
About the Company: Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are…
Experience: Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GCP quality/compliance role
Type: Full-time
Benefits: Flexible working environment, Competitive reward including annual company bonus, Medical, dental, and vision insurance …
Quality Control and Validation Manager Cambridge
Skills & Focus: quality control, validation, microbiology, GMP, aseptic manufacturing, regulatory submissions, process validation, analytical validation, standard operating procedures, collaborative
About the Company: Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are…
Experience: Experienced QC microbiology requirements for aseptic manufacturing
Type: Full-time
Benefits: 28 days annual leave, employer pension contribution, life assurance cover, private medical insurance, employee assistan…

Beam Therapeutics

Senior Manager / Associate Director – Clinical GCP Quality Cambridge
Skills & Focus: Good Clinical Practice, clinical compliance, quality systems, clinical study, GxP auditing, regulatory compliance, quality management, biotechnology, gene editing, clinical trial management
About the Company: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. Beam has assembl…
Experience: 10+ years of relevant experience in quality, 5+ in a GCP environment, with at least three years of demonstrated experience working with multi-disciplinary functional areas.
Type: Full-time

Relay Therapeutics

TMF Specialist Cambridge
Skills & Focus: TMF, eTMF, clinical studies, ICH-GCP, FDA, EMA, TMF QC, process improvement, Veeva Vault, problem-solving
About the Company: Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to…
Experience: 2-5 years industry experience with TMF/eTMF.
Type: Full-time

Astrazeneca

Principal Scientist, External Viral Vector Testing Cambridge
Skills & Focus: external QC activities, AAV product release, contract manufacturing organizations, quality control, regulatory compliance, scientific leadership, method validation, stability testing, GxP Change Control, analytical development
About the Company: AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, part…
Experience: PhD in biochemistry, biological science, chemistry, or chemical engineering (or related fields) with 4+ years of relevant experience, or BS/MS with 8+ years of experience.
Type: Full-time

Beam

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

Blueprint Medicines

Associate Director of Vendor and Audit Management Cambridge
Skills & Focus: Vendor Management, Audit Management, GxP Compliance, Quality Assurance, Regulatory Inspection, Team Management, Risk Management, Continuous Improvement, Clinical Research, Pharmaceutical Industry
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: Minimum of 7+ years of relevant experience in Biotechnology/Pharmaceutical industry; 5+ years' experience in the management of Vendor and Audit Programs GMP QA/QC/Compliance.

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

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

Beam Therapeutics

Manager/Senior Manager of External Manufacturing Cambridge
Skills & Focus: CMO management, contract management, project management, supplier management, cGMP operations, manufacturing service agreements, resource planning, KPI metrics, change management, cell and gene therapy
About the Company: Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembl…
Experience: 8+ years in biologics manufacturing, and 3+ years in a management or technical MSAT position
Type: Full-time

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

Parexel

Sr. Quality Assurance Auditor Cambridge
Skills & Focus: Quality Management, GCP, GXP, Auditor, Clinical Trials, Project Leadership, Clinical Research, Quality Assurance, Regulatory Consultants, Biostatisticians

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…

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

Boston Scientific

Clinical Database Analyst III Cambridge
Skills & Focus: Clinical Data, eCRF Design, Data Management, Collaboration, Medical Device, Data Integrity, Validation, Technical Design, Good Clinical Practices, User Acceptance Testing
About the Company: Boston Scientific is a leader in medical science for more than 40 years, committed to solving the challenges that matter most, united by a deep caring for huma…
Experience: Minimum 2 years of Clinical Database (eCRF) Design experience
Salary: $76,000 - $144,400
Type: Hybrid
Benefits: Competitive core and optional employee benefits

Egenesis

Quality Systems Specialist Cambridge
Skills & Focus: Quality Systems, Quality Assurance, GMP Manufacturing, Testing, Genome Editing, Cross-functional Interaction, Support, Implementation, Management, Impactful Position
About the Company: A biotechnology company focused on delivering safe and effective human transplantable cells, tissue, and organs utilizing the latest advancements in genome edi…

Parexel

Regulatory Affairs Jobs Cambridge
Skills & Focus: Regulatory Affairs, Consulting, Clinical, Remote, Medical Device, Drug, Labeling Operations, CMC, Senior Consultant, Technical Lead
Type: Remote

Teleflex

Quality Engineer II, Design Assurance Chelmsford
Skills & Focus: Quality Engineer, Design Assurance, Process Validation, Risk Management, Statistical Techniques, Process Controls, Documentation, Audits, Root Cause Analysis, Medical Device
About the Company: Teleflex Incorporated is a global provider of medical technologies, driven by their purpose to improve the health and quality of people’s lives, offering a div…
Experience: 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry)
Type: Contract
Senior Quality Engineer Chelmsford
Skills & Focus: Quality Assurance, Quality Management, CAPA, Nonconformance, ISO 13485, Auditing, Risk Management, Quality Improvement, Medical Devices, Supplier Quality
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: Minimum 5 years experience of Quality and/or related Manufacturing/Engineering experience in a manufacturing site
Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: Design Assurance, New Product Development, Risk Management, Test Method Development, Validation, Design Verification, Regulatory Affairs, Hazard Analysis, DFMEA, Test Protocols
About the Company: Teleflex is a global provider of medical technologies, driven by the purpose to improve the health and quality of people’s lives. They focus on becoming the mo…
Experience: Two years of related experience required.

Genezen

Validation Manager Lexington
Skills & Focus: validation, cGMP, protocol generation, environmental qualification, risk assessments, technical writing, aseptic fill finish, clean rooms, qualifications activities, data analysis
About the Company: Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene an…
Experience: 5-8 years of validation experience
Type: Full-time
Benefits: Paid vacation days, paid sick time, observed holidays, 401(k) plan with company match, healthcare plans, FSA and HSA pr…
QC Scientist - Critical Reagents Lexington
Skills & Focus: gene therapy, GMP, quality control, reference standards, ICH guidelines, cross-functional collaboration, statistical knowledge, biotech experience, SOP writing, analytical skills
About the Company: Genezen is a company in the gene therapy field providing process development, producing GMP viral vectors, and offering cell transduction for clinical trials, …
Experience: 8+ years of pharma/biotech industry experience
Senior Quality Assurance Specialist Lexington
Skills & Focus: Quality Management System, cGMP manufacturing, regulatory compliance, deviations, Corrective and Preventive Actions (CAPAs), manufacturing operations, batch record review, data integrity, internal and external audits, problem-solving skills
About the Company: Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene an…
Experience: 6-8 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Type: Full-time
Benefits: Paid vacation days based on tenure, Paid sick time, 10 observed holidays + 2 floating holiday + 1 volunteer day, 401(k)…

Rqm+

Senior Regulatory Affairs Specialist Marlborough
Skills & Focus: regulatory support, Endoscopy devices, post market design changes, international submission, commercial support, manufacturing support, compliance support, global medical device regulations, FDA-recognized laboratory, clinical trial design
About the Company: RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technol…
Type: Contract