GMP Operational Quality Senior Manager
Vertex Pharmaceuticals
June 24, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
- The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance, coordinating/executing activities on multiple complex projects and taking a role in the design and execution of new projects.
Key Duties and Responsibilities:
- Collaborate with internal/external business partners to resolve complex quality issues for compliant solutions.
- Participate in cross-functional teams as an experienced Quality technical resource.
- Draft/enforce Quality Agreements between CMOs/Suppliers and Vertex, as needed.
- Assist Change Control owners with ensuring compliance to change procedure requirements; assess and approve change controls.
- Conduct quality investigations/deviations; review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for deviations and OOS.
- Ensure appropriate CAPA actions are identified and addressed; approve investigations/CAPAs.
- Identify, facilitate, and/or lead continuous improvement efforts; maintain Quality Metrics.
- Provide tactics to address compliance gaps or recommend enhancements to cross-functional quality systems.
- Conduct GMP document review (procedures, work instructions, specifications, methods, protocols, and method reports).
- Coordinate/facilitate/follow up on QLT action items.
- Identify and communicate risks and assist with risk mitigation.
- Support internal/external audit programs; assist with audit responses; manage audit CAPAs & metrics.
- Provide technical advice for partner and regulatory agency audits; assist with budgeting/scheduling.
Knowledge and Skills:
- In-depth cGMP and global GMP knowledge for pharmaceutical manufacturing.
- Leadership in fast-paced environments; independent cross-functional leadership.
- Experience leading complex projects and continuous improvement using project management processes/tools.
- Mentor/guide others; communicate complex/sensitive information to influence alignment.
- Strong event investigations, RCA, and CAPA experience.
- Electronic document management systems experience (e.g., QDoccs, Trackwise, Veeva).
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- Typically 6 years of experience, or equivalent combination of education and experience.
- The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance, coordinating/executing activities on multiple complex projects and taking a role in the design and execution of new projects.
Key Duties and Responsibilities:
- Collaborate with internal/external business partners to resolve complex quality issues for compliant solutions.
- Participate in cross-functional teams as an experienced Quality technical resource.
- Draft/enforce Quality Agreements between CMOs/Suppliers and Vertex, as needed.
- Assist Change Control owners with ensuring compliance to change procedure requirements; assess and approve change controls.
- Conduct quality investigations/deviations; review corrective action plans for adequacy and compliance, including root cause analysis and product impact assessments for deviations and OOS.
- Ensure appropriate CAPA actions are identified and addressed; approve investigations/CAPAs.
- Identify, facilitate, and/or lead continuous improvement efforts; maintain Quality Metrics.
- Provide tactics to address compliance gaps or recommend enhancements to cross-functional quality systems.
- Conduct GMP document review (procedures, work instructions, specifications, methods, protocols, and method reports).
- Coordinate/facilitate/follow up on QLT action items.
- Identify and communicate risks and assist with risk mitigation.
- Support internal/external audit programs; assist with audit responses; manage audit CAPAs & metrics.
- Provide technical advice for partner and regulatory agency audits; assist with budgeting/scheduling.
Knowledge and Skills:
- In-depth cGMP and global GMP knowledge for pharmaceutical manufacturing.
- Leadership in fast-paced environments; independent cross-functional leadership.
- Experience leading complex projects and continuous improvement using project management processes/tools.
- Mentor/guide others; communicate complex/sensitive information to influence alignment.
- Strong event investigations, RCA, and CAPA experience.
- Electronic document management systems experience (e.g., QDoccs, Trackwise, Veeva).
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- Typically 6 years of experience, or equivalent combination of education and experience.