Director CMC Quality Compliance (Hybrid)

Vertex Inc. • Boston, MA

5d • $184,600 - $277,000 • Hybrid

About The Position

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. This position focuses not just on the “what” but the “how”, ensuring phase appropriate and risk-based compliance.

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 utilizing 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 proven ability to lead teams
• 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

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 in the regulatory space and incorporate into phase appropriate control strategies
• Responsible for overseeing internal and external sites, working with cross-functional teams to identify areas of compliance risk, and implementing action plans to improve the overall compliance and quality culture of the sites.
• Monitors health of the inspection readiness and management system, ensures appropriate escalations, and reports to leadership through established governance structure.
• Works across quality and functional areas to ensure inspection program is scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations
• Provides technical and strategic support to all areas including other quality groups for compliance and inspection related decisions.
• As a people manager within the organization, provides leadership, development and coaching to staff. Provides enterprise-level thinking and strategy direction to staff and acts as a change agent for improvements.

Benefits

• medical, dental and vision benefits
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Director