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Senior Associate Director, GMP Quality Release; API

Job in Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listing for: Madrigalpharma
Full Time position
Listed on 2026-07-11
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 223048.8 - 297398.4 USD Yearly USD 223048.80 297398.40 YEAR
Job Description & How to Apply Below
Position: Senior Associate Director, GMP Quality Release (API)

Madrigal is seeking an Associate Director, GMP Quality Release (Quality API) to lead batch review and release across API and intermediate batches, ensuring consistent, compliant, and timely disposition. This role maintains release narratives, escalation pathways, and audit-ready documentation while coordinating with CMOs/CDMOs to protect supply continuity.

The position requires 10–12+ years in GMP pharma/biotech, with strong knowledge of ICH Q7, Q8–Q10, and experience in API release; DP

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Position Requirements
10+ Years work experience
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