Director CMC Quality Compliance (Hybrid)

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 184,600 - 277,000; Full time

Job summary

Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will drive governance, risk-based strategies, and a high-quality culture across manufacturing and testing operations in support of Vertex's portfolio.

The role requires extensive GMP know-how, strategic leadership, and collaboration with cross-functional teams. This hybrid/on-site eligible position emphasizes scalable programs and staff development.

Qualifications

• Expert knowledge of global GMP requirements across multiple GxP areas.
• Ability to evaluate quality matters using a risk-based approach.
• Strong facilitation, communication, and coaching skills with leadership experience.

Responsibilities

• Accountable for inspection readiness and compliance programs across all GMP areas including external CMOs and internal sites.
• Monitor and interpret cGMP regulatory guidelines and trends and incorporate into phase-appropriate control strategies.
• Oversee internal and external sites, identify compliance risks, and implement action plans to improve quality culture.
• Monitor the health of the inspection readiness and management system and report to leadership.
• Collaborate across quality and functional areas to ensure scalable inspection programs, including new modalities.
• Provide technical and strategic support to all areas and serve as change agent for improvements.
• Lead and coach staff with enterprise-level thinking and direction.

Skills

GMP knowledge

Cross-functional collaboration

Risk-based decision making

GMP inspection management

Quality governance

Communication and coaching

Education

Bachelor's degree in a scientific or allied health field

10+ years of work experience with 3+ years of management

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.

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

Pay Range

$184,600 - $277,000

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This 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 a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to 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) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• 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.

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 [e-mail]