Associate Director, Product Quality & Compliance

BioSpace; Indianapolis (IN); Sur place; USD 117 000 - 189 000; Plein temps

Avantages offerts par ce poste

Company bonus

401(k) plan

Medical benefits

Dental benefits

Vision benefits

Life insurance

Well-being benefits

Résumé du poste

Lilly is seeking an Associate Director, Product Quality in the US to design and scale a robust Quality Management System for a growing development portfolio. You will provide GxP compliance oversight for internal functions and outsourced partners, ensuring robust supplier management and audit programs.

You will lead QA activities for regulatory submissions, product releases, and validation programs while mentoring a small team of QA professionals to maintain accountability and cross-functional

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, 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.

Responsabilités

• 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.

Formation

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

Outils

Document control software (ZenQMS, Veeva Vault, MasterControl)

Description du poste

Lilly is seeking an Associate Director, Product Quality in the US to design and scale a robust Quality Management System for a growing development portfolio. You will provide GxP compliance oversight for internal functions and outsourced partners, ensuring robust supplier management and audit programs.

You will lead QA activities for regulatory submissions, product releases, and validation programs while mentoring a small team of QA professionals to maintain accountability and cross-functional