Quality Control Associate Director

Job Description

Job Summary

Vertex is seeking a highly motivated and experienced Associate Director, Quality Control to join our External Manufacturing, Cell and Genetic Therapies (CGT) team. This role is pivotal in driving quality excellence and operational efficiency across our commercial CGT manufacturing sites and testing facilities. The successful candidate will lead key quality initiatives, develop and execute lifecycle management (LCM) strategies, and champion digital transformation within the Quality Control (QC) function. This is a hybrid role, offering a dynamic and collaborative work environment.

Key Responsibilities

• Develop and execute Lifecycle Management (LCM) strategies to ensure continuous improvement, scalability and compliance across QC processes, while retaining high focus on ongoing supply continuity for all markets.

• Act as a Digital Champion, driving initiatives with internal and external partners to evolve digital maturity, including digital integration of external data into the Vertex data platform and advanced data analytics.

• Lead Quality System improvements, including Out-of-Specification (OOS) management strategies, alignment, and execution.

• Collaborate with and provide oversight of Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs) to ensure quality standards are met and maintained.

• Represent QC in Change Control Governance and Endorsement Forums and Deviation Governance Teams.

• Lead Operational Excellence (OpEx) initiatives across CMO sites and CTLs, engaging Vertex OpEx leads for efficiencies and best practices.

• Prepare content and present CMO/CTL performance metrics and improvement initiatives for Quality Leadership Team (QLT) and Quality Management Review (QMR) meetings.

Qualifications

• Bachelor’s Degree in LifeScience or a related discipline is required.

• Proven experience in Quality Control within the pharmaceutical or biotechnology industry.

• Typically requires 10 years of experience in pharmaceutical/biopharmaceutical industry

• Strong expertise in LCM strategy development and execution.

• Demonstrated ability to lead quality system improvements

• Strong technical acumen to troubleshoot testing issues, lead investigations and manage OOS processes effectively.

• Experience working with CMOs/CTLs and effectively representing QC in governance forums.

• Proficiency in digital tools and systems, with a track record as a Digital Champion.

• Excellent leadership, communication, and collaboration skills.

Preferred Qualifications

• Advanced degree in a related field is a plus.

• Experience in leading cross-functional Operational Excellence (OpEx) initiatives.

• Familiarity with data integration and digital transformation in laboratory environments.

Pay Range:

Disclosure Statement:

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]