Quality Control Associate Director

Vertex Inc. • Boston, MA

1d • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director