Associate Director, Product Quality & Compliance

Eli Lilly; United States; Presencial; USD 117.000 - 189.000; Tempo integral

Resumo da vaga

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, seeks an Associate Director, Product Quality based in the US with up to 20% travel. You will design and scale a QMS, oversee GxP compliance with internal and external partners, and lead QA activities across deviations, CAPAs, and change control.

You will guide regulatory submissions, oversee tech transfers, and prepare for inspections, while mentoring a small QA team in a fast-paced, development-stage environment.

Qualificações

• 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.

Responsabilidades

• 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

Conhecimentos

GxP knowledge

Leadership

QMS design

Regulatory submissions

CDMO oversight

Quality oversight

Formação

BS or higher in Life Sciences, Chemistry, Pharmacy, or related field

Ferramentas

ZenQMS

Veeva Vault

MasterControl

Descrição da vaga

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, seeks an Associate Director, Product Quality based in the US with up to 20% travel. You will design and scale a QMS, oversee GxP compliance with internal and external partners, and lead QA activities across deviations, CAPAs, and change control.

You will guide regulatory submissions, oversee tech transfers, and prepare for inspections, while mentoring a small QA team in a fast-paced, development-stage environment.