Top 57 Biotechnology quality assurance Jobs in Boston Ma

Senior Manager, Operational Area Quality (Combination Products)
Vertex Pharmaceuticals —Boston, MA
- $133,800 - $200,600 a year
- Full-time
- Hybrid work
- Engineering
- Senior level
- Leadership
- Loan repayment program
- Dental insurance
GMP Operational Quality Senior Specialist (Stability)
Vertex Pharmaceuticals —Boston, MA
- $94,200 - $141,200 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Organizational skills
- Loan repayment program
- Dental insurance
Sr. Manager, GMP Quality Assurance
Deciphera Pharmaceuticals —Waltham, MA
- $138,000 - $190,000 a year
- Full-time
- Remote
- 8 years
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Quick Apply
Quality Assurance Manager
Ardelyx —Waltham, MA
- $139,000 - $169,000 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- SharePoint
- Paid parental leave
- Paid holidays
Quality Assurance Compliance Specialist I
Zoll Medical Corporation —Chelmsford, MA
- $60,000 - $70,000 a year
- Engineering
- Associate's degree
- Communication skills
11d
Associate Director, GMP Quality Assurance Operations
Kiniksa Pharmaceuticals —Lexington, MA
- $160,000 - $200,000 a year
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Office
Quick Apply
Senior Manager, Quality Assurance (RLT Manufacturing Ops)
Mariana Oncology —Watertown, MA
- $85,400 - $158,600 a year
- Full-time
- Hybrid work
- Senior level
- 10 years
Quick Apply
4d
Analytical Quality Assurance, Associate Director
Vertex Pharmaceuticals —Boston, MA
- $156,600 - $234,800 a year
- Full-time
- Master's degree
- 8 years
- Doctor of Philosophy
- Loan repayment program
- Dental insurance
Program Quality Associate Director, Assurance
Vertex Pharmaceuticals —Boston, MA
- $155,400 - $233,000 a year
- Full-time
- Hybrid work
- 5 years
- Master's degree
- Analysis skills
- Loan repayment program
- Dental insurance
2d
Sr. Quality Specialist, Material Management
Katalyst Healthcares & Life Sciences —Boston, MA
- Contract
- 5 years
- ERP systems
- Bachelor's degree
Quick Apply
Senior Manager, Corporate Quality – R&D Audits
Sarepta Therapeutics —Bedford, MA
- $136,000 - $170,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor's degree
- Travel
Manager, Quality Operations
Viridian Therapeutics, Inc. —Waltham, MA
- $118,000 - $145,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid parental leave
- AD&D insurance
Quick Apply
Director/Senior Director, GMP Quality Assurance Operations
Crescent Biopharma —Waltham, MA
- $200,000 - $260,000 a year
- Full-time
- 8 years
- Bachelor's degree
- Travel
- Paid holidays
- Disability insurance
Quick Apply
4d
Senior Scientist I, Quality Control
Candel Therapeutics —Needham, MA
- $155,000 - $160,000 a year
- Full-time
- Doctor of Philosophy
- US work authorization
- Computer skills
Associate Director, Quality Operations
Amylyx Pharmaceuticals —Cambridge, MA
- $172,000 - $194,000 a year
- 8 years
- Bachelor's degree
- Travel
Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $147,500 - $221,300 a year
- Full-time
- Hybrid work
- Management
- 8 years
- Bachelor's degree
- Loan repayment program
- Dental insurance
5d
Senior Director, Quality Control
EPM Scientific —Boston, MA
- Contract
- Bachelor's degree
- Mentoring
- US work authorization
Quick Apply
5d
QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals —Boston, MA
- $118,400 - $177,600 a year
- Full-time
- Hybrid work
- Bachelor's degree
- Product management
- Conflict management
- Loan repayment program
- Dental insurance
Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals —Boston, MA
- $137,800 - $206,800 a year
- Full-time
- Hybrid work
- 6 years
- Project management
- Bachelor's degree
- Loan repayment program
- Dental insurance
Associate Director, Global Inspection Management
Ultragenyx Pharmaceutical —Bedford, MA
- $179,600 - $221,900 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Children
- Gym membership
3d

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Senior Manager, Operational Area Quality (Combination Products)

Vertex Pharmaceuticals -
Boston, MA

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Job Details

Full-time
$133,800 - $200,600 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Regulatory inspections
Statistics
Communication with suppliers
Investigations regulatory compliance
Quality records maintenance
Supplier corrective action implementation
Preventive action implementation
Engineering
Document control experience within manufacturing industry
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
GMP
Internal investigations
Quality improvement leadership
Minitab
Vendor compliance audits
Supplier audits
Vendor compliance management
Bachelor's degree in engineering
Production validation processes
Quality risk management
Medical device manufacturing facility experience
Pharmaceutical company experience
Design failure mode and effects analysis (DFMEA)
Technology transfer (scale-up process)
Compliance documentation
Supplier development
Leading team collaboration initiatives
Regulatory/legal compliance standards in production

Full Job Description

Job Description

General Summary

The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products. The role is responsible for quality oversight of manufacturing operations, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance while partnering with manufacturing, engineering, supply chain, and external manufacturing partners. The position also supports design quality activities to ensure manufacturing changes remain aligned with design control and risk management requirements throughout the product lifecycle.

Key Duties and Responsibilities

Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring compliance with GMP, regulatory requirements, and internal quality systems.
Provide quality oversight for product disposition activities, including review and approval of manufacturing documentation to support timely release of clinical and commercial product.
Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation.
Lead and approve manufacturing deviations, investigations, nonconforming material reports (NCMRs), CAPAs, change controls, and effectiveness checks.
Conduct and lead root cause investigations using structured problem-solving methodologies and ensure implementation of effective corrective and preventive actions.
Support manufacturing operations by providing real-time quality oversight for assembly processes, equipment issues, process improvements, and manufacturing investigations.
Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements, disposition requirements, manufacturing investigations, and continuous improvement initiatives.
Support manufacturing process validation, equipment qualification, technology transfers, and process improvements to ensure products remain in a validated state.
Lead supplier quality activities including supplier investigations, supplier change assessments, supplier qualification, and quality issue resolution.
Support regulatory inspections, customer audits, supplier audits, and internal audits while ensuring timely responses and closure of observations.
Support complaint investigations and product quality assessments as required.
Support Design Quality activities by reviewing design changes, participating in design reviews, supporting Design History File maintenance, and ensuring manufacturing changes are appropriately evaluated through design controls and risk management.
Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle.

Knowledge and Skills

Strong experience supporting assembly manufacturing operations for medical devices and combination products.
Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records.
Strong knowledge of autoinjector and drug-device combination products, including assembly processes, manufacturing operations, supplier management, and product lifecycle support.
Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations.
Experience supporting process validation, equipment qualification, technology transfers, and manufacturing readiness.
Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers.
Working knowledge of Design Controls and Risk Management to support manufacturing quality activities and lifecycle changes.
Strong technical problem-solving, investigation, and root cause analysis skills.
Excellent leadership, communication, and cross-functional collaboration skills.
Experience with statistical analysis tools, Minitab, and quality engineering methodologies preferred.

Education and Experience

Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline is required. Advanced degree preferred.
Typically requires 10+ years of Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality experience within the medical device, biotechnology, pharmaceutical, or combination product industry.
Minimum of 5 years supporting GMP manufacturing operations, including assembly manufacturing, product disposition, deviation management, investigations, CAPA, change control, and batch record review.
Demonstrated experience supporting autoinjector, prefilled syringe, or other drug-device combination products from clinical through commercial manufacturing.
Experience leading cross-functional quality initiatives and partnering with Contract Manufacturing Organizations (CMOs) and suppliers.
Prior people leadership or demonstrated technical leadership of complex quality programs is preferred

Pay Range:

$133,800 - $200,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

biotechnology quality assurance jobs in boston ma

Senior Manager, Operational Area Quality (Combination Products)

GMP Operational Quality Senior Specialist (Stability)

Sr. Manager, GMP Quality Assurance

Quality Assurance Manager

Quality Assurance Compliance Specialist I

Associate Director, GMP Quality Assurance Operations

Senior Manager, Quality Assurance (RLT Manufacturing Ops)

Analytical Quality Assurance, Associate Director

Program Quality Associate Director, Assurance

Sr. Quality Specialist, Material Management

Senior Manager, Corporate Quality – R&D Audits

Manager, Quality Operations

Director/Senior Director, GMP Quality Assurance Operations

Senior Scientist I, Quality Control

Associate Director, Quality Operations

Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)

Senior Director, Quality Control

QA Manager- Finished Goods Commercial

Senior Manager, Clinical Study Quality Lead (Hybrid)

Associate Director, Global Inspection Management

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