Director CMC Quality Compliance

Regulatory Jobs; Boston (MA); Hybrid; USD 185,000 - 277,000; Full time

Benefits offered by this job

Hybrid work arrangement

Travel opportunities 5-10%

Job summary

Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems.

The role requires a Bachelor's in science and approximately 10 years of experience with 3 years in management, plus hybrid/on-site flexibility to advance quality culture across the organization.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 10 years of work experience and 3 years of management experience.

Responsibilities

• Accountable for inspection readiness across GMP sites and programs.
• Monitor cGMP regulatory guidelines and implement phase-appropriate strategies.
• Oversee internal and external sites with cross-functional teams to improve compliance and quality culture.
• Monitor health of the inspection readiness system and report to leadership.
• Ensure the inspection program is scalable and integrates new modalities.
• Provide technical and strategic support to all areas for compliance decisions.
• Lead, develop, and coach staff and drive enterprise-level strategy.

Skills

Global GMP knowledge

Cross-functional leadership

Risk-based decision making

GxP governance

Quality culture improvement

Facilitation and coaching

Education

Bachelor's degree in a scientific or allied health field

Job description

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

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

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:
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 [e-mail]