Director CMC Quality Compliance (Hybrid)

About the Role

The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites, including evaluating, improving, and monitoring commercial-level quality compliance and quality culture. This position provides technical and strategic leadership for inspection readiness and compliance, including processes and associated governance across all GMP areas. The role focuses on both the "what" and the "how," ensuring phase-appropriate and risk-based compliance.

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, incorporating them into phase-appropriate control strategies.
• Oversee internal and external sites, working with cross-functional teams to identify areas of compliance risk and implement action plans to improve overall compliance and quality culture.
• Monitor the health of the inspection readiness and management system, ensure appropriate escalations, and report to leadership through established governance structures.
• Ensure the inspection program is scalable and flexible, including integration of new modalities into quality systems as Vertex expands its scope of operations.
• Provide technical and strategic support to all areas, including other quality groups, for compliance and inspection-related decisions.
• As a people manager, provide leadership, development, and coaching to staff, acting as a change agent for improvements.
• Provide enterprise-level thinking and strategic direction to staff.

Requirements

• Expert knowledge of global GMP requirements and experience across multiple GxP areas.
• Highly collaborative and effective at building strong enterprise and cross-functional relationships; a strategic change leader who delivers results through influence, partnership, and leadership.
• Ability to evaluate quality matters and make decisions using a risk-based approach.
• Strong technical knowledge, including but not limited to: GMP regulations, inspection management, risk management, and quality governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance.
• Superb facilitation, communication, and coaching/influencing skills with a proven ability to lead teams.

Qualifications

• Bachelor's degree in a scientific or allied health field (or equivalent degree).
• Typically requires 10 years of work experience and 3 years of management experience, or the equivalent combination of education and experience.

5-10% travel may be required.

Pay

The pay range for this role is $184,600 - $277,000. This range is based on a reasonable estimate for the base salary pay range at the time of posting. The role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

Vertex offers inclusive market-leading benefits to support employees in their career, financial, family, and well-being journey. Benefits include:

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan and more.

Schedule

This is a Hybrid-Eligible role, allowing you to choose between:

• Hybrid: Work remotely up to two days per week.
• On-Site: Work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.