Director CMC Quality Compliance (Hybrid)

Job Description

General Summary:

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.

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 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.

Knowledge and Skills:

• 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

Education and Experience:

• 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

Other:

• 5-10% Travel may be required

#LI-hybrid #LI-JS1

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    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. 

#LI-Hybrid
 

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]