Associate Director, Product Quality

Lilly • Indianapolis, IN

3d • $117,000 - $189,200

About The Position

The Associate Director, Product Quality will help build and lead the quality function at Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company. The role ensures compliance with GxP regulations while supporting development and commercialization goals across the product pipeline. It calls for a strategic, hands-on contributor who can work tactically in a small, collaborative environment and provide quality oversight across internal processes and external partnerships, balancing regulatory compliance, operational efficiency, and business growth.

The position is based in the US and involves occasional travel, up to 20%.

Requirements

• BS or higher in Life Sciences, Chemistry, Pharmacy, or a related field.
• At least 8 years of experience in pharmaceutical quality roles, including at least 3 years in a leadership position.
• Experience with document control software such as ZenQMS, Veeva Vault, or 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 Haves

• 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.

Responsibilities

• Design, implement, and scale a Quality Management System (QMS) suited to the company’s development stage and product pipeline.
• Provide GxP compliance oversight for internal functions and outsourced partners, including CDMOs, CROs, and testing laboratories; ensure robust supplier management and audit programs.
• Lead quality activities, including deviations, CAPAs, change control, document control, and training.
• Serve as quality lead for regulatory submissions such as INDs, CTAs, and NDAs, clinical trial material release, and validation programs.
• Provide quality input for technology 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 and serve as a primary quality representative to health authorities.
• Hire, mentor, and lead a small team of QA professionals, fostering cross-functional communication and accountability.
• Perform other assigned responsibilities.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

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