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:
$158,400 - $237,600Disclosure 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 EligibleFlex 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]
Top Skills
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
