Associate Director, Product Quality

Eli Lilly and Company

. Design, implement, and scale a Quality Management System appropriate to the company’s stage of development and product pipeline .

Posted 10/15/2026full-timeRemote • United StatesSenior💰 $117,000 - $189,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems and GxP compliance, with a strong background in regulatory submissions and quality oversight in the pharmaceutical industry. Proven leadership in managing QA teams and fostering cross-functional collaboration to ensure operational efficiency and compliance.

Highest-signal resume keywords

Quality Management System DesignGxP Compliance OversightRegulatory Submissions ExperienceLeadership in Quality AssuranceDocument Control Software Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemGxP RegulationsRegulatory SubmissionsDocument ControlCAPA ManagementChange ControlBatch Record ReviewAnalytical Documentation ReviewSupplier ManagementQuality Best Practices

Soft Skills

LeadershipCommunicationCross-Functional CollaborationAccountabilityOperational Efficiency

Tools & Technologies

ZenQMSVeeva VaultMasterControl

Industry Keywords

Pharmaceutical QualityFDAEMAICHCDMO ManufacturingClinical Trial Material ReleaseRegulatory InspectionsEarly-Stage DevelopmentStartup Experience

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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%