Director CMC Quality Compliance (Hybrid)
Vertex Pharmaceuticals
August 18, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites, evaluating, improving, and monitoring commercial-level quality compliance and quality culture. Provides technical and strategic leadership for inspection readiness and compliance processes and governance across all GMP areas, with phase-appropriate, risk-based compliance.
Key Duties and Responsibilities:
- Accountable for inspection readiness, inspection management, and compliance programs across all GMP areas, including external CMOs and internal manufacturing/testing sites.
- Monitor and interpret cGMP regulatory guidelines and trends; incorporate into phase-appropriate control strategies.
- Oversee internal and external sites with cross-functional teams to identify compliance risks and implement action plans to improve compliance and quality culture.
- Monitor health of the inspection readiness and management system; ensure appropriate escalations and report through established governance.
- Ensure the inspection program is scalable and flexible, including integration of new modalities into quality systems as scope expands.
- Provide technical and strategic support for compliance and inspection-related decisions across quality groups.
- People management: lead, develop, coach staff; act as a change agent.
Knowledge and Skills:
- Expert global GMP/GxP knowledge.
- Ability to evaluate quality matters using a risk-based approach.
- Strong technical knowledge (GMP regulations, inspection management, risk management, quality governance).
- Strong quality culture influence; facilitation, communication, coaching, and team leadership.
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- Typically 10 years’ experience and 3 years’ management experience (or equivalent).
Other:
- 5–10% travel may be required.
Pay Range:
- $184,600 - $277,000
The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites, evaluating, improving, and monitoring commercial-level quality compliance and quality culture. Provides technical and strategic leadership for inspection readiness and compliance processes and governance across all GMP areas, with phase-appropriate, risk-based compliance.
Key Duties and Responsibilities:
- Accountable for inspection readiness, inspection management, and compliance programs across all GMP areas, including external CMOs and internal manufacturing/testing sites.
- Monitor and interpret cGMP regulatory guidelines and trends; incorporate into phase-appropriate control strategies.
- Oversee internal and external sites with cross-functional teams to identify compliance risks and implement action plans to improve compliance and quality culture.
- Monitor health of the inspection readiness and management system; ensure appropriate escalations and report through established governance.
- Ensure the inspection program is scalable and flexible, including integration of new modalities into quality systems as scope expands.
- Provide technical and strategic support for compliance and inspection-related decisions across quality groups.
- People management: lead, develop, coach staff; act as a change agent.
Knowledge and Skills:
- Expert global GMP/GxP knowledge.
- Ability to evaluate quality matters using a risk-based approach.
- Strong technical knowledge (GMP regulations, inspection management, risk management, quality governance).
- Strong quality culture influence; facilitation, communication, coaching, and team leadership.
Education and Experience:
- Bachelor’s degree in a scientific or allied health field (or equivalent).
- Typically 10 years’ experience and 3 years’ management experience (or equivalent).
Other:
- 5–10% travel may be required.
Pay Range:
- $184,600 - $277,000