QA Manager- Finished Goods Commercial
Vertex Pharmaceuticals
10 days ago
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The Quality Manager provides oversight of department activities to ensure alignment with corporate goals and regulatory requirements. Manages complex projects, troubleshoots issues, and collaborates with partners/stakeholders to ensure supply continuity. Oversees end-to-end Finished Goods product disposition, ensuring timely, compliant release through data readiness, CMO/internal collaboration, and continuous improvement.
Key Responsibilities
Product Disposition Management:
- Oversee Finished Goods disposition to meet regulatory/quality standards.
- Collaborate with CMOs to resolve disposition issues; align on timelines and expectations.
- Review Executed Batch Records for commercial packaging; resolve CMO comments.
- Review impacting change controls vs. full lot genealogy to determine regional material compliance; make disposition decisions and perform batch release.
- Evaluate Investigations/OOS/Change Controls to support disposition decisions.
- Assist with EAC and Material Review Board activities as needed.
- Manage disposition data readiness (batch records, CoAs, supporting documentation).
- Proactively improve disposition processes to meet turnaround times.
Stakeholder Collaboration:
- Lead/maintain QA relationships with one or more CMOs; act as primary QA contact for disposition questions/escalations.
- Partner with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
Compliance and Continuous Improvement:
- Provide quality guidance for root-cause analysis, impact assessments, and CAPA actions.
- Support GMP/GDP management reviews, risk assessments, and mitigation.
- Identify and implement process improvements for internal QA and vendor performance.
- Lead/represent FG QA on cross-functional continuous improvement initiatives.
Communication & Audit Support:
- Prepare/present quality and disposition performance reports (metrics, trends, risks, mitigations).
- Serve as SME responder for audit/inspection preparation, execution, and post-inspection.
Minimum Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related health field.
- 4+ years in pharma manufacturing (Packaging/Labeling preferred) OR QA OR Finished Goods disposition.
- Strong knowledge of global GMP and oral drug product manufacturing.
- Proficiency in data analysis/visualization tools.
- Excellent communication, collaboration, and project management.
Preferred Qualifications:
- Leadership in high-throughput environments; strong attention to detail.
- Critical thinking/problem solving; risk-based quality decision-making.
- Project management/continuous improvement; ability to lead cross-functional teams.
- Mentoring/technical knowledge transfer.
- Flexibility/adaptability; expertise in global GMP/GDP, RCA methods, broad GxP lifecycle knowledge, and escalation urgency.
The Quality Manager provides oversight of department activities to ensure alignment with corporate goals and regulatory requirements. Manages complex projects, troubleshoots issues, and collaborates with partners/stakeholders to ensure supply continuity. Oversees end-to-end Finished Goods product disposition, ensuring timely, compliant release through data readiness, CMO/internal collaboration, and continuous improvement.
Key Responsibilities
Product Disposition Management:
- Oversee Finished Goods disposition to meet regulatory/quality standards.
- Collaborate with CMOs to resolve disposition issues; align on timelines and expectations.
- Review Executed Batch Records for commercial packaging; resolve CMO comments.
- Review impacting change controls vs. full lot genealogy to determine regional material compliance; make disposition decisions and perform batch release.
- Evaluate Investigations/OOS/Change Controls to support disposition decisions.
- Assist with EAC and Material Review Board activities as needed.
- Manage disposition data readiness (batch records, CoAs, supporting documentation).
- Proactively improve disposition processes to meet turnaround times.
Stakeholder Collaboration:
- Lead/maintain QA relationships with one or more CMOs; act as primary QA contact for disposition questions/escalations.
- Partner with internal teams (MS&T, External Manufacturing, Supply Chain, Regulatory) to resolve quality events.
Compliance and Continuous Improvement:
- Provide quality guidance for root-cause analysis, impact assessments, and CAPA actions.
- Support GMP/GDP management reviews, risk assessments, and mitigation.
- Identify and implement process improvements for internal QA and vendor performance.
- Lead/represent FG QA on cross-functional continuous improvement initiatives.
Communication & Audit Support:
- Prepare/present quality and disposition performance reports (metrics, trends, risks, mitigations).
- Serve as SME responder for audit/inspection preparation, execution, and post-inspection.
Minimum Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related health field.
- 4+ years in pharma manufacturing (Packaging/Labeling preferred) OR QA OR Finished Goods disposition.
- Strong knowledge of global GMP and oral drug product manufacturing.
- Proficiency in data analysis/visualization tools.
- Excellent communication, collaboration, and project management.
Preferred Qualifications:
- Leadership in high-throughput environments; strong attention to detail.
- Critical thinking/problem solving; risk-based quality decision-making.
- Project management/continuous improvement; ability to lead cross-functional teams.
- Mentoring/technical knowledge transfer.
- Flexibility/adaptability; expertise in global GMP/GDP, RCA methods, broad GxP lifecycle knowledge, and escalation urgency.