Associate Director, Product Quality

Overview

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, 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.

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 involvement in successful regulatory submissions and inspections a plus.
• Early-stage development or startup experience preferred.
• Work Location:
• The Associate Director, Product Quality role is based in the US, with occasional travel (up to 20%).
• Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
• Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
• Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
• Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is