Senior Director, Clinical Supply Release & QA Excellence

Madrigal Pharmaceuticals

Conshohocken (Montgomery County)

On-site

USD 245,000 - 299,000

Full time

14 days+
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Job summary

At Madrigal Pharmaceuticals, we seek an experienced QA professional to own disposition and release of clinical supplies, ensuring compliant, audit-ready workflows and documentation. You will collaborate with Clinical Ops, CMC, Supply Chain, and vendors to prevent release bottlenecks and maintain inspection readiness.

The role requires 15+ years of GMP QA/release experience, strong documentation discipline, and travel up to 30% domestically and internationally.

Qualifications

  • BS in science or engineering or related field.
  • 15+ years GMP QA / release experience (clinical supply strongly relevant).
  • Strong documentation discipline and cross-functional coordination.
  • Willingness to travel 20–30% domestically and internationally.

Responsibilities

  • Own release criteria, checklists, and documentation standards, ensuring consistent, compliant disposition decisions.
  • Drive cycle-time and right-first-time improvements for clinical release workflows.
  • Produce deliverables such as release checklists, dashboards, and clinical release cycle-time reports.
  • Ensure QA oversight over clinical packaging runs and vendor oversight (as applicable).
  • Coordinate deviations / investigations / change controls impacting release timelines, with risk-based assessments.

Skills

Documentation discipline
Cross-functional coordination
Travel readiness

Education

BS in Science / Engineering

Job description

At Madrigal Pharmaceuticals, we seek an experienced QA professional to own disposition and release of clinical supplies, ensuring compliant, audit-ready workflows and documentation. You will collaborate with Clinical Ops, CMC, Supply Chain, and vendors to prevent release bottlenecks and maintain inspection readiness.

The role requires 15+ years of GMP QA/release experience, strong documentation discipline, and travel up to 30% domestically and internationally.

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