66 Quality Assurance And Engineering jobs in New York City.

Hiring now: Associate Dir Inspection @ Regeneron , Sr Mgr Cmc Regulatory Aff @ Regeneron, Sr Mgr Gd Quality Managem @ Regeneron , Spec Quality Eng @ L3Harris T, Regulatory Spec Fragrance @ Osmo, Dir Regulatory Cmc @ Eikon Ther, Sr Mgr Regulatory Affairs @ Stryker, Manufacturing Associate I @ Lgcgroup, Healthcare Quality Adviso @ Federal Ex, Cqv Eng Consultant @ Precision .Explore more at jobswithgpt.com.

🔥 Skills

cGMP (12) project management (11) compliance (8) regulatory compliance (7) quality assurance (7) Quality Control (7) Regulatory Affairs (6) Quality Assurance (6) manufacturing (6) product development (6)

đź“Ť Locations

New York City (20) Somerset (8) Bridgewater (8) Basking Ridge (7) Newark (6) Jersey City (4) Clifton (3) Princeton (3) Brooklyn (2) Millburn (2)
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Regeneron Pharmaceuticals Inc.

Associate Director Inspection Management (GCP) Basking Ridge
Skills & Focus: GCP, GVP, GLP, inspections, stakeholder engagement, regulatory compliance, quality management, clinical trials, training, risk mitigation
Experience: 10 years
Salary: $154,800.00 - $252,800.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off
Associate Director, Global Development Quality Management (GCP) Basking Ridge
Skills & Focus: quality management, compliance, quality assurance, audits, training, data analysis, industry standards, production, collaboration, proactive
About the Company: Regeneron is committed to excellence in quality management and ensuring the highest standards across its products and services.
Experience: At least 5 years of experience in a quality management role.
Type: Contract
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.

Regeneron

Senior Manager CMC Regulatory Affairs Basking Ridge
Skills & Focus: regulatory strategies, biologic products, cell and gene therapy, CMC product development, regulatory filing documents, FDA, EMA, advanced therapies, clinical trial applications, marketing authorizations
About the Company: Regeneron Pharmaceuticals, Inc. is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Experience: Minimum of 8 years in pharmaceutical/biotech industry experience including a minimum of 5 years of relevant CMC experience.
Salary: $132,400.00 - $216,000.00
Type: Full-time
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off.

Regeneron Pharmaceuticals

Senior Manager, GD Quality Management (GCP) Basking Ridge
Skills & Focus: Quality Management, GCP, compliance, clinical trials, risk management, stakeholders, audit, quality assurance, Corrective Action/Preventive Action, training
Experience: 8 years in healthcare/pharmaceutical industry
Salary: $132,400.00 - $216,000.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Regeneron Pharmaceuticals Inc.

Associate Director, GPS Standards & Training Basking Ridge
Skills & Focus: Pharmacovigilance, Drug Safety, Quality Management, Regulatory Affairs, Compliance, Project Management, Procedural Documentation, Training Compliance, Audits, Metrics
About the Company: Regeneron is a biotechnology company that develops and commercializes medicines for the treatment of serious medical conditions.
Experience: 7+ years in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry
Salary: $154,800.00 - $252,800.00
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Regeneron

Director IT Quality Assurance & Compliance Basking Ridge
Skills & Focus: IT Quality Assurance, Compliance, Leadership, Regulatory Compliance, GxP, Audit management, Risk Analysis, Process modeling, Continuous Improvement, Team Development
About the Company: Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. The company is committed to scientific …
Experience: 12+ years in IT quality assurance and compliance within the biopharmaceutical industry
Salary: $180,400.00 - $300,700.00
Type: Contract
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees

Regeneron Pharmaceuticals Inc.

Senior Manager, Veeva Vault Clinical SSU Basking Ridge
Skills & Focus: Clinical Operations, GxP validation, Veeva Technology systems, Agile development, project management, vendor relationship management, customer experience, product support, continuous improvement, product strategy
Experience: 8+ years in Clinical Operations management
Salary: $132,400.00 - $216,000.00
Type: Contract
Benefits: Health and wellness programs, fitness centers, equity awards, annual bonuses, paid time off

L3harris Technologies

Specialist, Quality Engineering Clifton
Skills & Focus: Quality Engineering, Hardware Quality Assurance, FRB/MRB activities, Root cause analysis, Corrective action, Quality discrepancies, ISO9001, AS9100, Process audit, Quality Management System
Experience: Minimum of 4 years’ experience with a Bachelor's Degree or 2 years’ experience with a Master's Degree
Senior Manager, Quality Assurance Clifton
Skills & Focus: Quality Assurance, process improvement, customer satisfaction, quality management, compliance monitoring, engineering, manufacturing, AS9100, leadership, program management
Experience: Minimum of 12 years of prior related experience or Graduate degree with a minimum of 10 years of prior related experience. 5+ years Quality management or operations leadership experience.
Specialist, Quality Engineering Clifton
Skills & Focus: Quality Assurance, Quality Engineering, root cause analysis, corrective action, metrics, project management, continuous improvement, ZDP execution, ISO9001, AS9100
About the Company: L3Harris Technologies is the Trusted Disruptor in the defense industry, delivering end-to-end technology solutions that connect space, air, land, sea, and cybe…
Experience: Bachelor’s Degree with a minimum of 4 years of experience in supporting design, development, manufacturing and/or quality engineering activities OR Master’s Degree with a minimum of 2 years of experience.

Osmo

Regulatory Specialist, Fragrance Manufacturing Elizabeth
Skills & Focus: regulatory compliance, fragrance, SDS preparation, IFRA, REACH, FDA, EPA, technical documentation, product registrations, risk assessments
About the Company: Osmo is a digital olfaction company focused on enhancing human health and wellbeing through the power of smell.
Experience: Minimum of 3-5 years of experience in regulatory affairs
Type: Full time

Eikon Therapeutics

Director, Regulatory CMC Jersey City
Skills & Focus: Regulatory, CMC, pharmaceutical, biotech, regulatory affairs, compliance, drug targets, submissions, inspections, team management
About the Company: Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolog…
Experience: Minimum of 3 days a week onsite presence; 10+ years of experience in regulatory affairs, focusing on CMC aspects of pharmaceutical products.
Salary: $213,000 to $232,750
Type: Full-time
Benefits: 401k plan with company matching, Medical insurance (premiums covered at 95%), dental and vision insurance (100%), menta…
Senior Director, Global Regulatory Affairs - Chemistry Manufacturing Controls (… Jersey City
Skills & Focus: global regulatory strategies, CMC regulatory expertise, NDA/MAA filings, regulatory submissions, quality control, technical documentation, health authority meetings, risk assessment, project management, collaboration
About the Company: Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolog…
Experience: 12+ years with a relevant Post Graduate degree or 15+ years with a Bachelor's degree
Salary: $239,000 to $261,250
Type: Full-time
Benefits: 401k plan with company matching, Medical, dental and vision insurance, Mental health and wellness benefits, Weeklong su…
Manager, Trial Master File (TMF) Operations Jersey City
Skills & Focus: Trial Master File, TMF, clinical trials, Quality Control, regulatory inspection, documentation, clinical study, Good Documentation Practices, eTMF, audit support
About the Company: Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolog…
Experience: 6+ years of experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree
Salary: $122,000 to $133,000
Benefits: 401k plan with company matching, Medical, dental and vision insurance, Mental health and wellness benefits, Paid time o…

Stryker

Senior Manager, Regulatory Affairs, Mako and Enabling Technologies Mahwah
Skills & Focus: Regulatory Affairs, medical device regulations, FDA, EU submissions, managerial experience, cross-functional collaboration, product life cycle, strategic oversight, health authority interactions, team development
About the Company: Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its c…
Experience: 10+ years of work experience in an FDA regulated industry, 2-3+ years of managerial/supervisory experience
Salary: $155,500.00 - $264,500.00 USD
Type: Full Time
Benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insur…

Lgcgroup

Manufacturing Associate I Newark
Skills & Focus: manufacturing, diagnostic products, manual equipment, semi-automated equipment, cGMP, SOPs, safety, quality, cleanroom, ISO 13485

Federal Express Corporation

Healthcare Quality Advisor-1 Newark
Skills & Focus: healthcare, quality assurance, management, project management, continuous improvement, business, transportation, logistics, supply chain, compliance
Experience: Five (5) years’ minimum experience required in healthcare quality
Salary: Indianapolis Pay Range: $6,511.62/month - $8,627.89/month; Newark Pay Range: $7,882.48/month - $10,444.28/month
Type: Full Time
Benefits: health, vision and dental insurance, retirement, and tuition reimbursement

Lgcgroup

Manufacturing Associate I Newark
Skills & Focus: Manufacturing, diagnostic products, cGMP, SOPs, ISO 13485, safety policies, work area maintenance, cross-training, lifting materials, cleanroom environment

Federal Express Corporation

Healthcare Quality Advisor Newark
Skills & Focus: healthcare quality assurance, compliance, continuous improvement, logistics, supply chain management, project management, Good Distribution Practice, Good Manufacturing Practice, customer relationship, deviation management
Experience: Five (5) years’ minimum experience required in healthcare quality in manufacturing, laboratories or distribution or closely related experience.
Salary: $7,882.48/month - $10,444.28/month
Type: Full Time
Benefits: health, vision and dental insurance, retirement, and tuition reimbursement.

Precision For Medicine, Manufacturing Solutions

CQV Engineering Consultant Newark
Skills & Focus: CQV Engineering, Project Management, Validation Life Cycle, Technical Documentation, Client Project Initiatives, Leadership, Mentoring, Business Development, Collaboration, Life Science
About the Company: The leading advanced therapy technical operations consulting company in the life science industry. Committed to advancing manufacturing to achieve operational …
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, Aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan with company match, Pa…

Lgcgroup

Manufacturing Associate I Newark
Skills & Focus: manufacturing, diagnostic products, cGMP, SOPs, ISO 13485, safety, labor, quality, equipment, cross-training

Kyowa Kirin North America

Product Quality Associate Princeton
Skills & Focus: cGMP, batch documentation, regulatory compliance, packaging, labeling, documentation, Corrective Actions, Preventative Actions, investigations, quality assurance
About the Company: Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in …
Experience: Minimum of one year of product quality specialist role within the pharmaceutical industry preferred
Type: Full-time

Church & Dwight

Research Engineer Princeton
Skills & Focus: innovation, formulation, product development, data analysis, technical support, project management, cGMP, laboratory studies, plant trials, ISO certification
About the Company: A company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination…
Experience: 5+ years of relevant experience
Type: Full-time

Syneos Health

SSU & Regulatory Specialist I Princeton
Skills & Focus: clinical trial, submission, approval timelines, financial aspects, standard operating procedures, regulatory authorities, site selection, contract negotiation, training records, quality control
About the Company: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medic…
Experience: Associate’s Degree or equivalent combination of education and training.
Salary: USD $42,300-79,900
Type: Hybrid
Benefits: Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock…

Parexel

Regulatory Affairs Jobs Somerset
Skills & Focus: Regulatory Affairs, Consulting, Home Based, Clinical, Technical, Medical Device, Senior Consultant, Labeling Operations, Temporary, Associate

Legend Biotech

Quality Systems IT Manager Somerset
Skills & Focus: GxP, Validation, Veeva, Management, LMS, Compliance, IT Operations, Pharmaceutical, Quality Systems, Biotech
About the Company: Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inc…
Experience: 10+ years of hands-on experience in implementation and support of computerized systems in regulated GxP environment.
Director, Regulatory CMC Somerset
Skills & Focus: regulatory, CMC, biotechnology, viral vector technology, global submissions, INDs, IMPDs, product development, regulatory guidelines, documentation
About the Company: Legend Biotech is a biotechnology company focused on developing innovative therapies for cancer and other serious diseases.
Experience: 10 years
Type: Full-time

Parexel

Clinical Technical Editor- FSP Somerset
Skills & Focus: Medical Writing, Technical Editing, Clinical Trials, Biostatistics, Data Management, Regulatory Affairs, Medical Sciences, Project Management, Consulting, Quality Management
About the Company: A global biopharmaceutical services organization with a strong commitment to delivering impactful, high-quality content in medical writing.
Type: Remote

Legend Biotech

Quality Operations Manager Somerset
Skills & Focus: Quality Assurance, GMP, Clinical, Cell Therapy, Aseptic Manufacturing, Leadership, Regulatory, Quality Control, Documentation, Process Improvement
About the Company: Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inc…
Experience: Minimum of 6 years of relevant work experience required.
Type: Full-time

Parexel

Sr. Quality Assurance Auditor GCP GXP Somerset
Skills & Focus: Quality Management, Quality Assurance, GCP, GXP, Auditor, Clinical Trials, Regulatory, Biostatistics, Clinical Research, Pharmaceutical

Legend Biotech

Sr. Manufacturing Systems Engineer Somerset
Skills & Focus: Manufacturing Execution System, MES, technical, implementation, Electronic Batch Record, system integration, support, change controls, regulatory requirements, collaboration
Experience: 7+ years experience working with Manufacturing Execution Systems (MES) in a Pharmaceutical or Biotech GxP manufacturing environment.

Parexel

Regulatory Affairs Jobs Somerset
Skills & Focus: Regulatory Affairs, Consulting, Medical Device, Clinical Regulatory Affairs, Labeling Operations, Home Based, Drug & Device Expert, Senior Regulatory Affairs Consultant, Regulatory Lead, Remote

Cognizant

MES EBR Author - Syncade Summit
Skills & Focus: MES Integration, Pharma Manufacturing, Electronic Batch Records, Implementation, GMP Regulations, ISA95, ISA88, Agile Environment, Automation Engineering, Data Management
About the Company: Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era.
Experience: 6+ years of experience implementing MES for Pharma manufacturing processes
Salary: $90,000 to $130,000
Type: Full-time
Benefits: Medical/Dental/Vision/Life Insurance, Paid holidays plus Paid Time Off, 401(k) plan and contributions, Long-term/Short-…

Cresilon

Medical Device R&D Project Manager Brooklyn
Skills & Focus: medical device, project management, biotechnology, product development, cross-functional teams, quality compliance, design control, PMP certification, risk management, innovation
About the Company: Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hyd…
Experience: A minimum of 6 years of technical project management experience in the medical device or biotechnology industry is REQUIRED; a minimum of 3 years in product development within the medical device industry is REQUIRED.
Salary: $100,000 - $160,000
Type: Full-time
Benefits: Competitive annual base salary range of $100,000 - $160,000, Paid Vacation, Sick, & Holidays, Medical, Dental, and Visi…
Medical Device Engineer Brooklyn
Skills & Focus: medical devices, product development, design control, FDA Quality System Regulations, regulatory compliance, Solidworks, experimental design, user needs, Lean Six Sigma, biomedical engineering
About the Company: Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hyd…
Experience: A minimum of 4+ years of product development experience; at least 2 years in a cGMP-regulated industry
Salary: $80,000 - $160,000
Type: Full-time
Benefits: Competitive annual base salary range of $80,000 - $160,000, Paid Vacation, Sick, & Holidays, Monthly MetroCard Reimburs…

Iqvia

Business Systems Configuration Analyst New York City
Skills & Focus: Business Systems, Configuration, Reporting, Data Integration, Low Code, Planview, LIMS, User Requirements, Client Requirements, GxP Compliance
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Two (2) years of experience supporting low code system implementations.
Salary: $87,000.00 - $145,000.00
Type: Full-time
Benefits: Comprehensive benefits programs designed to meet diverse well-being needs.

Veeva Systems

Senior Director of Manufacturing & Quality Strategy New York City
Skills & Focus: Manufacturing, Quality Strategy, Biopharmaceuticals, Industry Cloud, Customer Solutions, Stakeholder Relationships, Customer Success, Digital Technologies, Thought Leadership, Adoption and Growth
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.
Experience: Senior leadership with a deep understanding of the global life sciences quality and manufacturing space and associated digital technologies.
Type: Full-time
Benefits: Flexibility to work from home or in the office, support for customer and employee success.

Peloton

Sr. Engineer, Safety and Regulatory New York City
Skills & Focus: Product Safety, Regulatory Compliance, Consumer Goods, Fitness Equipment, Product Investigation, Root Cause Analysis, Certification Processes, Quality Tools, ASTM, UL
About the Company: Peloton (NASDAQ: PTON) provides Members with expert instruction, and world-class content to create impactful and entertaining workout experiences for anyone, a…
Experience: Over 7 years of experience in a product safety and regulatory role
Salary: $135,830—$183,370 USD
Type: Full-Time
Benefits: - Medical, dental and vision insurance - Generous paid time off policy - Short-term and long-term disability - Access t…

Selux

Manufacturing Engineer New York City
Skills & Focus: Manufacturing Engineer, Contract Manufacturing, cGMP, FDA guidelines, Product Development, NPI process, Validation and Verification, Good Manufacturing Processes, Supply Chain Management, Key Performance Indicators
About the Company: Selux’s mission is to preserve the lifesaving efficacy of antibiotics by providing diagnostic results in hours, rather than days. We are building a multidiscip…
Experience: 5+ years
Salary: $96K-$125K
Type: Part-time
Benefits: Competitive benefits package including healthcare, 401K match, stock option grants, open paid time off and supportive f…

New York City Department Of Social Services

Principal Administrative Associate II New York City
Skills & Focus: Quality Control, Case Review, SNAP, Eligibility Criteria, Audit, Documentation, Corrective Action, Interviews, Federal QC, Regulations
About the Company: The DSS Accountability Office is responsible for protecting the integrity of social services programs administered by the New York City Department of Social Se…
Type: Full-time
Principal Administrative Associate II New York City
Skills & Focus: Quality Control, Case Review, SNAP, Eligibility Criteria, Audit, Documentation, Corrective Action, Interviews, Federal QC, Regulations
About the Company: The DSS Accountability Office is responsible for protecting the integrity of social services programs administered by the New York City Department of Social Se…
Type: Full-time
Principal Administrative Associate II New York City
Skills & Focus: Quality Control, Case Review, SNAP, Eligibility Criteria, Audit, Documentation, Corrective Action, Interviews, Federal QC, Regulations
About the Company: The DSS Accountability Office is responsible for protecting the integrity of social services programs administered by the New York City Department of Social Se…
Type: Full-time

Valo Health

Senior Electrical Engineer New York City
Skills & Focus: electrical engineering, medical device development, programming skills, CAD, microcontrollers, FPGA, project management, signal processing, biomedical engineering, ISO 13485
About the Company: Valo Health is a technology company that is integrating human-centric data and AI-powered technology to accelerate the creation of life-changing drugs for more…
Experience: 7+ years in electrical engineering, with 2+ years in a senior role
Salary: $129,000 - $158,000 USD
Type: Full-time

Carter's Inc.

Product Quality and Compliance Specialist New York City
Skills & Focus: regulatory labeling, product safety, compliance standards, documentation, quality assurance, testing, international regulations, children's products, project management, organizational skills
About the Company: Carter’s Inc. is the largest North American apparel retailer exclusively for babies and young children, encompassing Carter’s, OshKosh B’gosh, Skip*Hop and Lit…
Experience: 2+ years of experience
Salary: $67,000 - $75,000 a year
Type: Full Time

Formation Bio

Director, Medical Writing New York City
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 New York City
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.

Pfizer

Medical Quality Excellence Lead New York City
Skills & Focus: Medical Quality Oversight, Compliance, Regulatory Affairs, Quality Management System, Medical Evidence Generation, Healthcare, Pharma, Audit Readiness, Data Quality, Risk Management
About the Company: We innovate every day to make the world a healthier place.
Experience: 15 years' experience
Salary: $242,000.00 to $403,400.00
Type: Full time
Benefits: Comprehensive and generous benefits including 401(k), paid vacation, health benefits.

Maesa

Senior Manager, Regulatory New York City
Skills & Focus: regulatory, compliance, safety standards, claims substantiation, product lifecycle, leadership, team development, domestic & global standards, cross-functional teams, regulatory guidance
About the Company: The next gen beauty company, Maesa is transforming the industry by incubating and growing meaningful, innovative brands and making prestige beauty accessible.
Experience: 6+ years
Salary: $110,000 - $130,000
Type: Hybrid
Benefits: Health insurance coverage, wellness programs, life and disability insurance, retirement savings plans, generous paid ti…

Formation Bio

Director, Quality Management Systems New York City
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.

Eversana1

Director, Medical Writing New York City
Skills & Focus: medical writing, regulatory compliance, scientific content, team leadership, quality control, client communication, strategic support, project management, training, cross-department collaboration

Ro

Director of Packaging Development New York City
Skills & Focus: packaging engineering, user experience, cross-functional collaboration, strategic leadership, packaging design, patient-centric, regulatory compliance, scalability, automation, innovation
About the Company: Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possi…
Type: Full-time
Benefits: Recognized as a Fortune Best Workplace in New York and Health Care, Best Workplace for Parents, named in CNBC Disruptor…

Eight Sleep

Health Products Lead New York City
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…

Veeva Systems

Senior Director - Manufacturing & Quality Strategy New York City
Skills & Focus: manufacturing, quality strategy, life sciences, customer engagement, biopharmaceuticals, digital technologies, thought leadership, customer solutions, quality management systems, stakeholder relationships
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.
Experience: 12+ years of life sciences consulting and cloud software experience
Salary: $125,000 - $300,000
Type: Full-time
Benefits: Medical, dental, vision, and basic life insurance; Flexible PTO and company paid holidays; Retirement programs; 1% char…

Peloton

Sr. Program Manager - Product Safety/Regulatory New York City
Skills & Focus: Product Safety, Regulatory Compliance, Consumer Goods, Fitness Equipment, Safety Standards, 3rd Party Certification, Root Cause Analyses, DFMEA, Quality Tools, Continuous Improvement
About the Company: Peloton (NASDAQ: PTON) provides Members with expert instruction, and world class content to create impactful and entertaining workout experiences for anyone, a…
Experience: Over 7 years in a product safety and regulatory role, experience in consumer goods/fitness equipment a plus.
Salary: $135,830 — $183,370 USD
Type: Full-time
Benefits: Medical, dental and vision insurance; Generous paid time off policy; Short-term and long-term disability; Access to men…

Novartis

QA Operations Specialist Millburn
Skills & Focus: QA, GxP, cGMP, quality oversight, manufacturing, regulatory interactions, validation, qualification, data integrity, compliance
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…
Experience: 2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations, 1+ years of experience in a quality assurance role
Process Expert Millburn
Skills & Focus: nuclear medicine, targeted radioligand therapy, manufacturing, technical support, process expert, deviation investigations, CAPA, data analysis, quality requirements, team management
About the Company: Novartis is an innovative medicines company that works to improve and extend people's lives through advanced medical treatments and therapies.
Type: Full-time

Cellares

Principal Enterprise Architect, GMP Systems Bridgewater
Skills & Focus: Enterprise Architect, GMP Systems, cell therapy, manufacturing facility, IDMO IT strategy, infrastructure development, planning, design, implementation, coordination
About the Company: Cellares is focused on developing innovative cell therapy solutions.
Senior Manager, Raw Material Bridgewater
Skills & Focus: Senior Manager, Raw Material, Quality Assurance, cGMP, Supply Chain, Warehouse, Testing, Releasing, Biologics, Cell Therapy

Bausch Health

Senior Regulatory Affairs Specialist Bridgewater
Skills & Focus: Regulatory Strategy, Compliance, Documentation, Product Development, International Submissions, Analytical Reasoning, Communication Skills, Interpersonal Skills, Risk Management, Pharmaceutical Industry
About the Company: We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and …
Experience: 2+ years of relevant pharmaceutical industry and regulatory experience; brand experience preferred
Benefits: Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, F…

Cellares

Computer System Validation (CSV) Engineer Bridgewater
Skills & Focus: Quality Engineering, FDA-regulated environment, cGMP, GAMP 5, multidisciplinary, product life cycle, product development, production builds, market release, fast-paced environment
About the Company: Cellares is focused on advanced cell therapy manufacturing.
Senior Quality Assurance Specialist, Quality Operations Bridgewater
Skills & Focus: Quality Assurance, Quality Operations, cGMP, manufacturing operations, Disposition activities, QA shop floor support, Quality Assurance review, QC laboratory oversight, process implementation, cell therapy
About the Company: Cellares is focused on cell therapy manufacturing operations and quality assurance.

Bausch Health

Director, Regulatory Affairs (Global Labeling) Bridgewater
Skills & Focus: labeling, regulatory affairs, drug products, guidance, strategic development, cross-functional teams, labeling documents, health authority interactions, risk assessment, medical concepts
About the Company: Bausch Health is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufa…
Experience: 8+ years of relevant experience in pharmaceutical labeling/regulatory experience.
Benefits: Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, F…

Johnson & Johnson

Senior Project Manager, Quality Standards Bridgewater
Skills & Focus: Project Management, Quality Standards, Medical Device, Regulatory Compliance, Leadership, Risk Management, Budget Planning, Communication, Team Management, FDA Guidelines
About the Company: Johnson & Johnson is a leading global healthcare company that focuses on delivering innovative healthcare solutions across various medical fields.
Experience: Minimum of 8 years in the medical device or pharmaceutical industries
Salary: 120,000 to 207,000
Type: Hybrid