QA Manager Jobs in Boston, MA
QA Manager jobs in Boston are concentrated in the Seaport District, Kendall Square, and the Longwood Medical Area, across life sciences, medtech, and enterprise software. Employers actively hiring include Vertex Pharmaceuticals, PwC, and Surt AI. See the openings below and apply to the ones that match your experience.
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Job Description
General Summary:
The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. The role is responsible for establishing product quality standards for both established and emerging technologies, ensuring alignment with regulatory expectations and industry best practices, and proactively identifying and mitigating product quality risks throughout the product lifecycle and end to end patient journey.
This position partners closely with Manufacturing, Technical Operations, Regulatory Affairs, and Quality stakeholders to support program execution and governance, ensuring business, regulatory, quality, and operational objectives are achieved while maintaining the highest standards of patient safety and product quality.
Key Duties and Responsibilities:
Process Lifecycle Management
Serve as a Quality Assurance Subject Matter Expert (SME) for product and process lifecycle management, ensuring compliance with GxP regulations, and Vertex Quality Management System (QMS) including personalized medicine requirements.
Lead QA review and approval of stage-gate deliverables, process development activities, technology transfers, process validations, and new product introductions across the product lifecycle.
Drive the development, implementation, and maintenance of quality and compliance frameworks, standards, and strategies to ensure products and processes remain aligned with evolving regulatory and industry CGT expectations.
Partner with Development, Technical Operations, Manufacturing, and Supply Chain functions to support continuous improvement initiatives throughout development to commercialization.
Support preparation and review of process-related specifications, development reports, validation documentation, and regulatory submissions, including responses to Health Authority inquiries.
Serve as the Quality representative on CMC Governance forums to ensure compliant lifecycle strategies, technical transfers, and manufacturing changes.
Compliance & Investigations
Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
Partner with cross-functional teams to identify product, process and quality and compliance risks, assess impact, and implement appropriate mitigation strategies.
Support inspection readiness activities and participate in Health Authority inspections, regulatory interactions, information requests, and corrective action commitments.
Support development of Vertex quality systems and processes.
Identify, facilitate, and/or lead continuous improvement efforts
Technical Operations & CMO Management
Provide Quality oversight and strategic partnership for internal manufacturing operations and external contract manufacturing organizations (CMOs) supporting product lifecycle activities.
Support implementation of standardized quality practices, lifecycle management strategies, and continuous improvement initiatives across internal and external manufacturing networks.
Digital & Artificial Intelligence
Demonstrate understanding of digital manufacturing, process lifecycle management platforms, data analytics, automation technologies, and emerging AI applications within regulated GxP environments.
Utilize digital tools, advanced analytics, and AI-enabled solutions to enhance quality oversight, risk management, process monitoring, and operational decision-making.
Leverage systems such as MES, eQMS, data visualization platforms, process monitoring tools, and advanced analytics to assess product quality performance throughout the lifecycle
Knowledge and Skills:
- In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
- Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience.
- Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and presence.
- Critical Thinking and Problem Solving skills
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree)
- Preferred additional Master’s degree at Business /Scientific level
- 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
#LI-Hybrid
Pay Range:
$156,600 - $234,800Disclosure 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 EligibleFlex 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 ApplicationAssistance@vrtx.com
Job Description
General Summary:
The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. The role is responsible for establishing product quality standards for both established and emerging technologies, ensuring alignment with regulatory expectations and industry best practices, and proactively identifying and mitigating product quality risks throughout the product lifecycle and end to end patient journey.
This position partners closely with Manufacturing, Technical Operations, Regulatory Affairs, and Quality stakeholders to support program execution and governance, ensuring business, regulatory, quality, and operational objectives are achieved while maintaining the highest standards of patient safety and product quality.
Key Duties and Responsibilities:
Process Lifecycle Management
Serve as a Quality Assurance Subject Matter Expert (SME) for product and process lifecycle management, ensuring compliance with GxP regulations, and Vertex Quality Management System (QMS) including personalized medicine requirements.
Lead QA review and approval of stage-gate deliverables, process development activities, technology transfers, process validations, and new product introductions across the product lifecycle.
Drive the development, implementation, and maintenance of quality and compliance frameworks, standards, and strategies to ensure products and processes remain aligned with evolving regulatory and industry CGT expectations.
Partner with Development, Technical Operations, Manufacturing, and Supply Chain functions to support continuous improvement initiatives throughout development to commercialization.
Support preparation and review of process-related specifications, development reports, validation documentation, and regulatory submissions, including responses to Health Authority inquiries.
Serve as the Quality representative on CMC Governance forums to ensure compliant lifecycle strategies, technical transfers, and manufacturing changes.
Compliance & Investigations
Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
Partner with cross-functional teams to identify product, process and quality and compliance risks, assess impact, and implement appropriate mitigation strategies.
Support inspection readiness activities and participate in Health Authority inspections, regulatory interactions, information requests, and corrective action commitments.
Support development of Vertex quality systems and processes.
Identify, facilitate, and/or lead continuous improvement efforts
Technical Operations & CMO Management
Provide Quality oversight and strategic partnership for internal manufacturing operations and external contract manufacturing organizations (CMOs) supporting product lifecycle activities.
Support implementation of standardized quality practices, lifecycle management strategies, and continuous improvement initiatives across internal and external manufacturing networks.
Digital & Artificial Intelligence
Demonstrate understanding of digital manufacturing, process lifecycle management platforms, data analytics, automation technologies, and emerging AI applications within regulated GxP environments.
Utilize digital tools, advanced analytics, and AI-enabled solutions to enhance quality oversight, risk management, process monitoring, and operational decision-making.
Leverage systems such as MES, eQMS, data visualization platforms, process monitoring tools, and advanced analytics to assess product quality performance throughout the lifecycle
Knowledge and Skills:
- In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
- Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience.
- Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and presence.
- Critical Thinking and Problem Solving skills
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent degree)
- Preferred additional Master’s degree at Business /Scientific level
- 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
#LI-Hybrid
Pay Range:
$156,600 - $234,800Disclosure 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 EligibleFlex 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 ApplicationAssistance@vrtx.com
See All 70 QA Manager Jobs in Boston
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Find QA Manager JobsQA Manager Job Market in Boston
Who's Hiring
Top Industries Hiring
- Technology & Software
- Healthcare & Medical Services
- Consulting & Professional Services
QA Manager Jobs in Boston: Frequently Asked Questions
How do I get a qa manager job in Boston?
Target Boston's life sciences corridor in Kendall Square and the Longwood Medical Area, where biotech and medtech firms consistently need qa managers with regulatory experience. Enterprise software and fintech employers in the Seaport and Back Bay also hire steadily. Candidates who come in with FDA compliance knowledge, CAPA experience, or software testing leadership stand out in Boston's market over generalist quality backgrounds.
Which companies hire qa managers in Boston?
Boston qa manager roles are posted by Vertex Pharmaceuticals, PwC, and Surt AI and others right now, based on current listings on Migrate Mate as of August 2026. The hiring mix skews heavily toward biotech, medical device, and health technology companies, with a secondary cluster of software and financial services employers spread across downtown and the Seaport District.
Are there remote qa manager jobs in Boston?
Yes, though availability depends heavily on the role: software and analytical qa work is far more remote-friendly than hands-on lab, manufacturing, or device inspection roles. About 43% of qa manager openings tied to Boston are remote or hybrid as of August 2026, with most flexibility sitting in software QA and process quality positions rather than regulated lab or production environments.
How can I get a qa manager job in Boston with little or no experience?
The most realistic entry path in Boston is moving into a qa manager role from a QA engineer, QA analyst, or quality specialist position at one of the city's many mid-size biotech or software firms. Boston's startup ecosystem in Kendall Square and the Seaport regularly promotes internally, so joining a growing company as a senior individual contributor and stepping into management is a common local path. Certifications like ASQ's CQE or ISTQB also strengthen a Boston application.
Which industries hire the most qa managers in Boston?
Most qa manager openings in Boston sit in Technology & Software, Healthcare & Medical Services, and Consulting & Professional Services, per current listings on Migrate Mate as of August 2026. Boston's dense concentration of pharmaceutical, biotech, and medical device companies, combined with a mature enterprise software sector, creates sustained demand that outlasts national hiring cycles in most other cities.
Related Jobs in Massachusetts
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