Associate Director, Product Quality

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

** Overview*
* Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate - cleminorexton (formerly ORX
750) - is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a  
** Great Place to Work** ® in 2026.

The Associate Director, Product Quality is responsible for helping build and lead the quality function that ensures compliance with GxP regulations and supports the company's development and commercialization goals of our product pipeline. This role requires a dynamic contributor with a strategic mindset and the ability to operate tactically in a small, collaborative environment. This role will own quality oversight across internal processes and external partnerships, balancing regulatory compliance, operational efficiency, and business growth.

** Responsibilities:*
* + 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

*
* Basic Qualifications:

*
* + 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, Master Control).

+ 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.

*
* Preferred Qualifications:

*
* + 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…