LillyHiring

Associate Director, Product Quality

  • Remote, United States
  • Lead
  • Posted 2 weeks ago
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In one line

Quality leadership role at a small clinical-stage drug company, building the quality system and overseeing GxP compliance with outside manufacturers and labs.

About the role

The company is developing medicines for narcolepsy and other sleep-wake disorders, and the quality function has to grow with the pipeline. The person in this seat sets up the systems, faces regulators and audits, and leads a small QA group.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Skills
GxP, Veeva Vault, MasterControl, ZenQMS, CMC
Posted
15 Oct 2026
Last checked
29 Oct 2026

What you will do

  • Design and scale a quality management system that fits the company's stage and pipeline
  • Oversee GxP compliance for internal teams and outside partners such as CDMOs, CROs and testing labs
  • Run deviations, CAPAs, change control, document control and training
  • Act as quality lead for regulatory filings, clinical material release and validation
  • Give quality input on tech transfers, CMC work and scale-up plans
  • Review batch records, product release and analytical and manufacturing documents

What they look for

  • Eight or more years in pharmaceutical quality, with at least three in a leadership role
  • Experience with document control software such as ZenQMS, Veeva Vault or MasterControl
  • Solid knowledge of GxP rules from FDA, EMA and ICH across the product lifecycle
  • Familiarity with several dosage forms and CDMO-based manufacturing

Nice to have

  • A record of working well with limited resources and tight timelines

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Questions about this job

Can I do this job remotely, and from which countries?

Yes. The posting lists Associate Director, Product Quality as a remote role for candidates in the United States.

What does this job pay?

The posting does not state a salary, so there is no figure to quote.

What experience is needed?

It is a lead role. The posting asks for: eight or more years in pharmaceutical quality, with at least three in a leadership role; experience with document control software such as ZenQMS, Veeva Vault or MasterControl; solid knowledge of GxP rules from FDA, EMA and ICH across the product lifecycle. Skills it names include GxP, Veeva Vault, MasterControl, ZenQMS.

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