Associate Director, Product Quality

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $117k - $189.2k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Design, implement, and scale a Quality Management System appropriate to the company’s stage of development and product pipeline • Provide GxP compliance oversight for internal functions and outsourced partners, including CDMOs, CROs, and testing labs • Ensure 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, including INDs, CTAs, and 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 • Foster cross-functional communication and a culture of accountability • Perform other responsibilities as assigned • Help build and lead the quality function supporting compliance with GxP regulations and product development and commercialization goals

🎯 Requirements

• 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, such as ZenQMS, Veeva Vault, or MasterControl • Strong knowledge of GxP regulations, including FDA, EMA, and ICH, and quality best practices across the product lifecycle • Familiarity with multiple dosage forms and CDMO-based manufacturing • 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 is a plus • Early-stage development or startup experience preferred

🏖️ Benefits

• Company bonus depending, in part, on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Occasional travel up to 20%