Associate Director, Product Quality

Overview

The Associate Director, Product Quality helps build and lead the quality function that ensures GxP compliance and supports the development and commercialization goals of the product pipeline at Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company.

What you'll do

• Design, implement, and scale a Quality Management System (QMS) appropriate to the company's stage of development and product pipeline.
• Provide GxP compliance oversight for internal functions and outsourced partners (CDMOs, CROs, testing labs), ensuring robust supplier management and audit programs.
• Lead Quality function activities, including deviations, CAPAs, change control, document control, and training.
• Serve as quality lead for regulatory submissions (e.g., INDs, CTAs, NDAs), clinical trial material release, and validation programs.
• Drive quality input for tech transfers, CMC activities, and scale-up plans.
• Oversee batch record review, product release, and Quality review of analytical and manufacturing documentation.
• Prepare the company for regulatory inspections and third-party audits; serve as a primary quality representative to health authorities.
• Hire, mentor, and lead a small team of QA professionals, fostering cross-functional communication and a culture of accountability.
• Other responsibilities assigned.

What you'll need

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
• 8+ years of experience in pharmaceutical quality roles, including 3+ years in a leadership position.
• Experience with document control software (e.g., ZenQMS, Veeva Vault, MasterControl).
• Strong knowledge of GxP regulations (FDA, EMA, ICH) and quality best practices across the product lifecycle.
• Familiarity with multiple dosage forms and CDMO-based manufacturing.

Nice to have

• Proven ability to operate effectively in a resource-constrained, fast-paced setting.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Ability to balance compliance rigor with operational efficiency.
• Prior involvement in successful regulatory submissions and inspections.
• Early-stage development or startup experience.

Details

• Based in the US; fully remote role.
• Occasional travel (up to 20%).
• Full-time equivalent employee; eligible for company bonus.