Associate Director, Product Quality

BioSpace; Indianapolis (IN); On-site; USD 117,000 - 189,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Dental benefits

Vision benefits

Life insurance

Well-being benefits

Job summary

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.

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.

Education

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

Tools

Document control software (ZenQMS, Veeva Vault, MasterControl)

Job description

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—and 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 ORX750) – 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.

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.

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 $117,000 - $189,200.

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
• Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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