Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
Vertex Pharmaceuticals
August 18, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
- The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites, including evaluating, improving, and monitoring commercial level quality compliance and quality culture.
Key Duties And Responsibilities:
- Own inspection readiness and compliance programs for external operations; work cross-functionally/cross-company to ensure sites achieve and maintain inspection readiness.
- Drive identification and resolution of issues, gaps, and risks via collaboration, assessments, audits, and trend evaluation.
- Support and oversee inspection execution, including responses and closure of CAPAs.
- Integrate across functions; foster collaboration and knowledge sharing; develop trusted partnerships with external sites.
- Drive optimization, continuous improvement, and operational excellence.
- Report inspection readiness status and risks to leadership and governance forums.
Knowledge And Skills:
- Knowledge of global regulatory requirements and inspection expectations.
- Experience in multiple modalities (preferred).
- Strong technical knowledge (inspection management, risk management).
- Continuous improvement (e.g., Six Sigma or Lean).
- Lead improvement projects/teams and organize forums.
- Facilitation, communication, and coaching/influencing skills; lead teams.
- Identify and analyze performance indicators.
Education And Experience:
- Bachelor’s degree in a scientific discipline, allied health field, or equivalent.
- 8+ years of relevant experience.
Travel/Work Location:
- Up to 10–20% travel, including international.
- Hybrid: remote up to two days/week or On-Site: five days/week with ad hoc flexibility.
Pay Range:
- $147,500–$221,300; eligible for annual bonus and annual equity awards.
- The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites, including evaluating, improving, and monitoring commercial level quality compliance and quality culture.
Key Duties And Responsibilities:
- Own inspection readiness and compliance programs for external operations; work cross-functionally/cross-company to ensure sites achieve and maintain inspection readiness.
- Drive identification and resolution of issues, gaps, and risks via collaboration, assessments, audits, and trend evaluation.
- Support and oversee inspection execution, including responses and closure of CAPAs.
- Integrate across functions; foster collaboration and knowledge sharing; develop trusted partnerships with external sites.
- Drive optimization, continuous improvement, and operational excellence.
- Report inspection readiness status and risks to leadership and governance forums.
Knowledge And Skills:
- Knowledge of global regulatory requirements and inspection expectations.
- Experience in multiple modalities (preferred).
- Strong technical knowledge (inspection management, risk management).
- Continuous improvement (e.g., Six Sigma or Lean).
- Lead improvement projects/teams and organize forums.
- Facilitation, communication, and coaching/influencing skills; lead teams.
- Identify and analyze performance indicators.
Education And Experience:
- Bachelor’s degree in a scientific discipline, allied health field, or equivalent.
- 8+ years of relevant experience.
Travel/Work Location:
- Up to 10–20% travel, including international.
- Hybrid: remote up to two days/week or On-Site: five days/week with ad hoc flexibility.
Pay Range:
- $147,500–$221,300; eligible for annual bonus and annual equity awards.