Director, External Quality Control & Stability

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.

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.

Analytical Oversight and Tactical Support

Develop and Lead analytical quality control strategy across multiple programs.

Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates, as required.

Support analytical method transfer, as required

Collaborate on supplier qualification and/or remediation activities.

Stability Program Leadership

Oversee the stability program design and execution across multiple programs.

Monitor and report on stability trends and product quality attributes as required.

Ensure ongoing regulatory compliance of stability activities.

Supplier Oversight

Manage supplier ongoing relationships.

Perform routine reviews of testing results and overall quality of documentation.

Drive issue resolution to facilitate regulatory compliance.

Regulatory Support

Provide tactical support for regulatory submissions

Support health authority inspections and audits, as required.

Review analytical and stability sections within CMC filings.

BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.

10+ years quality control and analytical development experience.

Experience developing strategic vision as well as providing tactical support for quality control programs

The Director, External Quality Control & Stability role is a remote role based in the US.

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