QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals
August 09, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. Manages multiple complex projects, troubleshoots issues, and collaborates with business partners/stakeholders to support supply in all markets. Oversees end-to-end Finished Goods product disposition, ensuring timely and compliant release through data readiness and continuous improvement with CMOs and internal teams.
Key Responsibilities
Product Disposition Management:
- Oversee Finished Goods product disposition per regulatory/quality standards.
- Collaborate with CMOs to resolve disposition issues and align on timelines/quality expectations.
- Review Executed Batch Records (EBRs) for commercial packaging operations and resolve CMO comments.
- Review change controls vs. full lot genealogy; determine compliance by region(s); make disposition decisions and perform batch release.
- Evaluate Investigations/OOS/Change Controls to support disposition decisions.
- Support EAC and Material Review Board activities (when necessary).
- Manage disposition data readiness (batch records, CoA, supporting documentation) and improve turnaround times.
Stakeholder Collaboration:
- Manage QA relationships with one or more CMOs; act as primary QA contact for disposition queries/escalations.
- Collaborate with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
Compliance & Continuous Improvement:
- Provide guidance for root-cause analysis, impact assessments, and CAPA actions.
- Support GMP/GDP reviews, risk assessments, and mitigation; implement process improvements.
- Lead/represent FG QA in cross-functional initiatives.
Audit & Inspection Support:
- Serve as SME responder for audit/inspection preparation, execution, and post-inspection activities.
Minimum Qualifications:
- Bachelor’s degree in Life Sciences/Pharmacy/related field.
- 4+ years in pharmaceutical manufacturing (Packaging/Labeling preferred), QA, or Finished Goods disposition.
- Strong global GMP knowledge and oral drug product manufacturing practices.
- Data analysis/visualization tools proficiency.
- Excellent communication, collaboration, and project management.
Preferred Qualifications:
- Leadership; thrive in high-throughput environments; attention to detail.
- Critical thinking/problem solving; risk-based quality decisions.
- Project management/continuous improvement experience.
- Independent work on large projects; lead cross-functional teams; mentor/teach junior staff.
- Expert GMP/GDP knowledge, root-cause analysis tools, broad GxP lifecycle knowledge, urgency/escalation.
Pay Range:
- $118,400 - $177,600
The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. Manages multiple complex projects, troubleshoots issues, and collaborates with business partners/stakeholders to support supply in all markets. Oversees end-to-end Finished Goods product disposition, ensuring timely and compliant release through data readiness and continuous improvement with CMOs and internal teams.
Key Responsibilities
Product Disposition Management:
- Oversee Finished Goods product disposition per regulatory/quality standards.
- Collaborate with CMOs to resolve disposition issues and align on timelines/quality expectations.
- Review Executed Batch Records (EBRs) for commercial packaging operations and resolve CMO comments.
- Review change controls vs. full lot genealogy; determine compliance by region(s); make disposition decisions and perform batch release.
- Evaluate Investigations/OOS/Change Controls to support disposition decisions.
- Support EAC and Material Review Board activities (when necessary).
- Manage disposition data readiness (batch records, CoA, supporting documentation) and improve turnaround times.
Stakeholder Collaboration:
- Manage QA relationships with one or more CMOs; act as primary QA contact for disposition queries/escalations.
- Collaborate with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
Compliance & Continuous Improvement:
- Provide guidance for root-cause analysis, impact assessments, and CAPA actions.
- Support GMP/GDP reviews, risk assessments, and mitigation; implement process improvements.
- Lead/represent FG QA in cross-functional initiatives.
Audit & Inspection Support:
- Serve as SME responder for audit/inspection preparation, execution, and post-inspection activities.
Minimum Qualifications:
- Bachelor’s degree in Life Sciences/Pharmacy/related field.
- 4+ years in pharmaceutical manufacturing (Packaging/Labeling preferred), QA, or Finished Goods disposition.
- Strong global GMP knowledge and oral drug product manufacturing practices.
- Data analysis/visualization tools proficiency.
- Excellent communication, collaboration, and project management.
Preferred Qualifications:
- Leadership; thrive in high-throughput environments; attention to detail.
- Critical thinking/problem solving; risk-based quality decisions.
- Project management/continuous improvement experience.
- Independent work on large projects; lead cross-functional teams; mentor/teach junior staff.
- Expert GMP/GDP knowledge, root-cause analysis tools, broad GxP lifecycle knowledge, urgency/escalation.
Pay Range:
- $118,400 - $177,600