Last updated: 2025-05-22

75 Quality Assurance And Engineering jobs in Boston.

Hiring now: Regulatory Cmc Spec @ Orchard Th, Sr Validation Engr @ Cai, Svp Of Regulatory And Qua @ Ascidian T, Program Leader Medtech Qu @ Veeva Syst, Associate Dirdir Quality @ Strand The, Dir Medical Writing @ Formation , Prod Mgr Cms Regulatory S @ Pa Consult, Consultant Manufacturing @ Kyverna Th, Experienced Or Sr Supplie @ Boeing, Customer Success Associat @ Ketryx.Explore more at at kaamvaam.com

🔥 Skills

compliance (13) project management (11) GMP (11) collaboration (10) Quality Assurance (10) continuous improvement (9) regulatory compliance (8) GxP (8) risk management (7) cGMP (7)

📍 Locations

Boston (22) Cambridge (19) Waltham (9) Chelmsford (6) Lexington (4) Marlborough (4) Peabody (3) Woburn (3) Quincy (2) Watertown (2)
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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

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…

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

Strand Therapeutics

Associate Director/Director, Quality Assurance Operations Boston
Skills & Focus: Quality Operations, GMP, clinical trial, biotech, regulations, partnering, compliance, audits, risk-based approach, product quality
About the Company: Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunother…
Experience: 10+ years of quality operations experience in biotech
Salary: commensurate with role and experience
Type: Full-time
Benefits: health, dental, life, open PTO, onsite lunch catering, commuter support and more

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

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…

Kyverna Therapeutics

Consultant, Manufacturing and Supply (Contract) Boston
Skills & Focus: manufacturing, supply chain, change controls, project management, cell therapies, cGMP, regulatory, process development, risk management, continuous improvement
Experience: 2+ years in pharmaceutical manufacturing, technology transfer & process development; at least 1 year in cell therapies
Type: Contract

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.

Boeing

Experienced or Senior Supplier Quality Specialist (Level 3 or Level 4) Boston
Skills & Focus: Supplier Quality, Audits, Supplier Management, Root Cause Analysis, Corrective Action, Quality Systems, Regulatory Compliance, Training Development, Risk Assessment, Continuous Improvement
About the Company: Aerospace company creating products and services for the world and beyond.
Experience: 3+ years in Quality, Supplier Quality or Supplier Management; 3+ years with RCCA and CAPA; 3+ years with AS9100 or similar QMS standard
Salary: $70,550 - $148,350 (depending on location and level)
Type: Full-time
Benefits: Health insurance, retirement savings plans, tuition assistance, fertility, adoption, surrogacy benefits, and more.

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.

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

Ketryx

Solutions Engineer Boston
Skills & Focus: Medical Device Sales, medical device software, software as medical device, SaMD, Software systems engineer, software in a medical device, SiMD, software systems engineering, software verification, software validation
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 2 years of experience in customer success, technical support, sales engineering, or related.
Salary: $100,000 - $110,000 base + equity options *OTE may be negotiated based on experience level
Type: Full-time
Benefits: Competitive compensation, generous stock options, hybrid work model, generous PTO

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…

General Dynamics Ordnance And Tactical Systems

Document Ctrl Sr Specialist (Solid Rocket Motor) Boston
Skills & Focus: Document Control, Quality Assurance, Technical Documentation, Change Management, Configuration Management, Engineering Change Data, Product Development, Specifications, Technical Information, Document Approval
About the Company: General Dynamics Ordnance and Tactical Systems (GD-OTS) is a premier provider to the US Department of Defense and allied nations, involved in the design, engin…
Experience: 5-7 years experience
Type: Full Time
Benefits: compensation; healthcare, wellness, retirement, and work/life benefits that include a hybrid work option, career develo…

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

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…

Seaport Therapeutics

Sr Manager, QA Document Control & Training Boston
Skills & Focus: Document Control, GxP, Quality, Regulatory, Standard Operating Procedures, Training, Compliance, Records Management, Electronic Document Management Systems, Project Management
About the Company: Seaport Therapeutics has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its propriet…
Experience: 6-8 years
Type: Hybrid

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…

Johnson & Johnson

Sr. Director Systems Engineering & Testing - Orthopaedics Enabling Technology Boston
Skills & Focus: Systems Engineering, Testing, Orthopaedics, Digital Technology, Robotics, Medical Devices, Requirements Analysis, Validation and Verification, Risk Management, Product Development
About the Company: A multinational corporation known for its healthcare products, including pharmaceuticals, medical devices, and consumer health goods.

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.

Biogen

Senior Regulatory CMC Device Lead Cambridge
Skills & Focus: regulatory CMC, medical devices, combination products, regulatory strategies, regulatory submissions, cross-functional teams, compliance, cGMP, regulatory intelligence, analytical abilities
About the Company: Biogen is dedicated to improving the lives of people living with serious neurological and neurodegenerative diseases. We bring innovative therapies to patients…
Experience: 5+ years of regulatory experience in the pharmaceutical or biotechnology industry.
Type: Hybrid

Amylyx Pharmaceuticals

Manager, Inventory Management and Planning Cambridge
Skills & Focus: Inventory Management, Supply Chain, Forecasting, Clinical Supply, Demand Analysis, Supply Planning, Inventory Reconciliation, QMS, Supply Chain Systems, GxP
About the Company: Amylyx is a clinical-stage pharmaceutical company focused on developing therapies for high unmet medical needs, including PBH, Wolfram syndrome, PSP, and ALS.
Experience: 5+ years of relevant experience in the Pharmaceutical Industry or relevant educational background

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 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
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

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

Lila Sciences

Facility Director/Senior Director Cambridge
Skills & Focus: facilities management, biotech, pharmaceutical, life sciences, buildout, operations, vendor management, compliance, safety, collaboration
About the Company: Lila Sciences is a privately held, early-stage technology company pioneering the application of artificial intelligence to transform every aspect of the scient…
Experience: 10+ years of experience in facilities management, ideally within a biotech, pharmaceutical, or life sciences environment.

Blueprint Medicines

GxP Training Program Manager Cambridge
Skills & Focus: GxP Training, Procedural Document Control, eDMS, eLMS, Quality Culture, Regulatory Agencies, Training Program Management, GxP Software, Standard Operating Procedures, Quality Principles
Experience: 6+ years in industry with at least 5 years in training and document control

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

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

Senior Regulatory CMC Device Lead Cambridge
Skills & Focus: Regulatory CMC, medical devices, combination products, regulatory strategies, submissions, compliance, cross-functional teams, project assignments, legislative developments, analytical abilities
Experience: 5+ years of regulatory experience
Type: Hybrid

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

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

Scholar Rock

Head of Global GxP Quality Cambridge
Skills & Focus: GxP, Quality, Regulatory Compliance, GMP, GCP, GLP, Quality Systems, Post-market Surveillance, Global Operations, Leadership
About the Company: Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for serious diseases with high unmet needs. The comp…
Experience: 15+ years of experience in biopharmaceutical Quality leadership roles
Type: Full-Time

Aditum Bio

Associate Director / Director R&D Quality Assurance Cambridge
Skills & Focus: GxP, GCP, GLP, Quality Assurance, Regulatory Compliance, Audit, CAPA, RCA, Quality Management System, Clinical Research
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: At least 10 years within pharmaceutical and/or biotech industry
Salary: $175,000 to $215,000 depending on experience plus bonus, equity, and benefits
Type: Full-time
Benefits: Medical, dental, vision, disability, life, 401k plan with match, flexible PTO, paid holidays, sick leave, parental leave

Relay Therapeutics

Manager, Quality Systems Cambridge
Skills & Focus: Quality Management System, vendor management, GxP, auditing, compliance, continuous improvement, risk assessment, Quality ambassador, Veeva QualityDocs, Inspection Readiness
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: 4+ years of experience in pharma/biotech Vendor Management and auditing.

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

Senior Engineer II, Downstream Development, Viral Vector Product Development Cambridge
Skills & Focus: viral vector, downstream development, AAV manufacturing, purification, tech transfer, biotech industry, process development, regulatory submissions, scale-up, job-related knowledge
About the Company: AstraZeneca is driven by a commitment to help more patients by strengthening its pipeline and growing its area, focusing on holistic patient care.
Experience: 10+ years (BS), 8+ years (MS), or 2+ years (PhD) in the biotech industry
Salary: $110,000 to $166,000
Type: Full-time
Benefits: Includes 401(k), paid vacation, health benefits (medical, dental, vision), short-term incentive bonus, equity-based lon…

Teleflex

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.

Teleflex Incorporated

Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: design assurance, new product development, risk management, design controls, design verification, validation, test method development, regulatory affairs, sustaining engineering, quality system
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.

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
Sr. Quality Assurance Manager Chelmsford
Skills & Focus: Quality Assurance, Quality Engineering, Manufacturing, Continuous Improvement, FDA, ISO, CAPAs, Team Management, Process Optimization, Supplier Quality
About the Company: Teleflex is a global provider of medical technologies dedicated to improving the health and quality of people’s lives by providing a diverse portfolio of solut…
Experience: Minimum of 5 years related quality experience in a manufacturing environment; Minimum of 2 years of supervisory or management experience.
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.

Teleflex Incorporated

Quality Engineer 2, Design Assurance Chelmsford
Skills & Focus: design assurance, new product development, risk management, test method validation, design verification, FDA regulations, ISO13485, collaboration, quality systems, data analysis
About the Company: Teleflex is a global provider of medical technologies focused on improving health and quality of life through a diverse portfolio in various therapy areas.
Experience: Two years of related experience required.

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…
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…
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…

Boston Scientific

Medical Device Toxicologist II Marlborough
Skills & Focus: toxicology, biocompatibility, ISO 10993, medical devices, regulatory standards, toxicity assessments, biological evaluation, risk assessment, glp studies, medical device development
About the Company: A leader in medical science for over 40 years, committed to solving healthcare challenges with innovative solutions to improve patient lives.
Experience: 2-3 years supporting medical devices
Salary: $72,800 - $138,300
Type: Hybrid (Onsite and Remote)

Quest Diagnostics

Senior Quality Engineer Marlborough
Skills & Focus: Quality Assurance, Design Control, Validation, Root Cause Analysis, Manufacturing processes, ISO requirements, CAPAs, Document Control, Statistical analysis, Improvement projects
Experience: Five to Eight years related experience in IVD, medical, pharmaceutical, or other related industry.
Type: Full-Time

Boston Scientific

Principal Product Risk Specialist Marlborough
Skills & Focus: clinical product risk, risk analysis, regulatory standards, clinical evaluation reports, literature searches, risk assessment, clinical risk documents, FDA, safety signal detection, medical device
About the Company: A leader in medical science dedicated to solving health industry challenges through innovative solutions.
Experience: 5+ years in life sciences, engineering, or related field; 10+ years preferred
Salary: $99,100 - $188,300
Type: Hybrid
Benefits: Not specified in the posting
Senior Regulatory Affairs Specialist Marlborough
Skills & Focus: Regulatory Affairs, medical devices, FDA regulations, EU MDR, product development, submissions, compliance, regulatory strategies, clinical trials, sustaining engineering
About the Company: Boston Scientific specializes in medical devices for urology and other health conditions, aiming to improve patient lives through innovative solutions.
Experience: Minimum 4 years in Regulatory Affairs or related discipline in medical devices or drugs
Salary: $82,600 - $156,900
Type: Hybrid
Benefits: Comprehensive employee benefits package including health insurance, retirement plans, and professional development oppo…

Johnson & Johnson

Quality Inspection I Peabody
Skills & Focus: quality control, inspection, medical device, microscope, GMP, ISO, GCP, data entry, visual inspection, manual inspection
About the Company: A global healthcare company dedicated to producing innovative medical products and solutions.
Experience: 1 year or less in a manufacturing environment
Salary: $21-28/hr
Type: Full-time
Benefits: Medical, dental, vision, life insurance, disability, 401(k), paid time off, performance bonuses.
Senior Supplier Quality Engineer Peabody
Skills & Focus: Supplier Assessment, Quality Standards, Quality Audits, Supplier Performance, Root Cause Analysis, Quality Improvement, Regulatory Compliance, Risk Management, Collaboration, Documentation
About the Company: Johnson & Johnson is a global leader in healthcare innovation. Their strength in healthcare empowers them to build a world where complex diseases are prevented…
Experience: Minimum of 4 years of professional Engineering experience
Type: Full-time
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…

J.Jill

Associate Manager, Quality Assurance (Accessories) Quincy
Skills & Focus: Quality Assurance, manufacturing, risk assessment, wear-test program, collaboration, corrective action, regulatory compliance, quality control, product development, sourcing strategy
About the Company: J.Jill is a national lifestyle brand that provides apparel, footwear and accessories designed to help its customers move through a full life with ease.
Experience: 3+ years related experience.
Type: Full-time
Benefits: Flexible hybrid work arrangements, 401(k) retirement plan with discretionary match and tuition reimbursement, medical, …

Boston Scientific

Product Builder I Quincy
Skills & Focus: assemble, operate equipment, inspect in-process medical devices, maintain quality, building product, production goals, quality assurance, manufacturing process, compliance, regulatory policies
Experience: 0 Years with high school diploma/degree/equivalent
Salary: $32,552 - $55,328
Type: Onsite

Tessera Therapeutics

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…

Dyne Therapeutics

SVP, Head of Pharmacovigilance Waltham
Skills & Focus: pharmacovigilance, risk management, regulatory requirements, safety culture, strategic implementation, cross-functional collaboration, CROs, safety assessments, post-market surveillance, clinical regulatory documents
About the Company: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leve…
Experience: At least 20 years of experience in the pharmaceutical or biotech industry, including a minimum of 10 years in patient safety and pharmacovigilance.

Ardelyx

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…
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…
Executive Director, Quality Management and GxP Systems Waltham
Skills & Focus: Quality Management, GxP Systems, Regulatory Compliance, Quality Assurance, SOP Development, Audit Management, Vendor Qualification, CAPAs, Validation, Quality Trends
About the Company: A publicly traded commercial biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to meet unmet medical nee…
Experience: 15+ years in pharmaceutical quality systems and GxP Systems
Salary: $257,000-$314,000 annually
Type: Full-time
Benefits: Health plans, 401(k) match, paid parental leave, paid holidays, and more.

Dyne Therapeutics

Director, Drug Safety & Pharmacovigilance Scientist Waltham
Skills & Focus: pharmacovigilance, signal detection, risk management, regulatory compliance, documentation, training and development, safety reports, data analysis, collaboration, Good Pharmacovigilance Practices
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 10 years of experience in pharmacovigilance, with at least 2 years in a leadership role

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

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.

Landmark Bio

Associate Director Supply Chain Watertown
Skills & Focus: Supply Chain, Clinical Supply Chain, Manufacturing, Inventory Control, Production Planning, Material Enrollment, Customer Satisfaction, GMP Compliance, KPI Monitoring, Continuous Improvement
About the Company: Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-…
Experience: 5+ years of experience working in a cGMP role with on-site manufacturing required.
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

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
Sr. Program Manager-Radiopharmaceutical Woburn
Skills & Focus: radiopharmaceutical, radiochemistry, product development, clinical studies, regulatory submission, manufacturing processes, product design, clinical application, commercialization, project management
About the Company: Sirtex specializes in radiopharmaceutical programs and radiochemistry with focus on new product development, technical transfer, clinical studies, regulatory s…

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