Director Clinical Quality & Development Operations Inspection Excellence
Vertex Pharmaceuticals
2 months ago
Remote friendly (Boston, MA)
United States
Operations
General Summary:
Director, Clinical Quality & Development Operations (CQDO) Inspection Excellence supports Global Clinical Operations (GCO) audit/inspection management by planning, coordinating, and providing pre/post inspection support to ensure compliance with health authority regulations (e.g., FDA, EMA). Contributes to regulatory intelligence and helps build sustained inspection readiness.
Responsibilities:
- Lead inspection readiness/preparation for GCO (SME training/prep; back-room support; manage back-room during inspections).
- Risk-analyze and implement readiness strategy/program; provide lessons learned after each inspection.
- Contribute to audit/inspection planning, response generation; participate in internal process audits.
- In collaboration with AIM, develop/approve annual internal audit schedule.
- Oversee GCO quality events; support CAPA plans and investigations; ensure remediation and implementation.
- Manage/communicate lessons learned across studies; drive continuous improvement.
- Collaborate cross-functionally with GCQ, Regulatory Affairs, GPS; execute business strategy; serve as SME.
- Mentor junior staff/FSP personnel; people management (may include financial/account and HR responsibilities).
Qualifications/Requirements:
- Advanced understanding of GCP, CFR, ICH, and health authority regulations.
- 10 years biopharmaceutical industry experience (or equivalent); 3 years supervisor/management experience.
- Demonstrated inspection readiness leadership across multiple agencies (FDA, EMA, MHRA, PMDA, CDE).
- Experience applying risk-based quality (e.g., QbD) in regulated/pharmaceutical environments.
Knowledge/Skills:
- Expert in inspection concepts; strong analytical/detail orientation; advanced tools/process knowledge; results oriented; strong communication; global/cross-functional collaboration.
Compensation/Benefits (explicitly stated):
- Pay range: $184,000–$276,000; annual bonus and annual equity awards.
- Remote-Eligible (Remote/Hybrid/On-Site options).
Application Instructions:
- For accommodation requests: ApplicationAssistance@vrtx.com
Director, Clinical Quality & Development Operations (CQDO) Inspection Excellence supports Global Clinical Operations (GCO) audit/inspection management by planning, coordinating, and providing pre/post inspection support to ensure compliance with health authority regulations (e.g., FDA, EMA). Contributes to regulatory intelligence and helps build sustained inspection readiness.
Responsibilities:
- Lead inspection readiness/preparation for GCO (SME training/prep; back-room support; manage back-room during inspections).
- Risk-analyze and implement readiness strategy/program; provide lessons learned after each inspection.
- Contribute to audit/inspection planning, response generation; participate in internal process audits.
- In collaboration with AIM, develop/approve annual internal audit schedule.
- Oversee GCO quality events; support CAPA plans and investigations; ensure remediation and implementation.
- Manage/communicate lessons learned across studies; drive continuous improvement.
- Collaborate cross-functionally with GCQ, Regulatory Affairs, GPS; execute business strategy; serve as SME.
- Mentor junior staff/FSP personnel; people management (may include financial/account and HR responsibilities).
Qualifications/Requirements:
- Advanced understanding of GCP, CFR, ICH, and health authority regulations.
- 10 years biopharmaceutical industry experience (or equivalent); 3 years supervisor/management experience.
- Demonstrated inspection readiness leadership across multiple agencies (FDA, EMA, MHRA, PMDA, CDE).
- Experience applying risk-based quality (e.g., QbD) in regulated/pharmaceutical environments.
Knowledge/Skills:
- Expert in inspection concepts; strong analytical/detail orientation; advanced tools/process knowledge; results oriented; strong communication; global/cross-functional collaboration.
Compensation/Benefits (explicitly stated):
- Pay range: $184,000–$276,000; annual bonus and annual equity awards.
- Remote-Eligible (Remote/Hybrid/On-Site options).
Application Instructions:
- For accommodation requests: ApplicationAssistance@vrtx.com