Associate Director, Quality Change Management
Madrigal Pharmaceuticals · Conshohocken -, PA
QualityFull-time$164k–$201kCompany career page
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Role summary
Madrigal Pharmaceuticals seeks an Associate Director of Quality Change Management to lead change control governance across internal operations and external manufacturing partners. The role emphasizes risk-based assessment, cross-functional alignment, and inspection-ready documentation to support the company's biopharmaceutical operations.
What they're looking for
- Bachelor's degree or higher in science, engineering, or related field
- 10-12 years of GMP quality assurance and quality management system experience
- Demonstrated leadership in change control governance and risk-based decision making
- Cross-functional collaboration and executive-level communication skills
- Veeva Vault Quality (eQMS) proficiency for end-to-end change management
- Pharmaceutical or biotech post-approval and external manufacturing change experience (preferred)
What you'll be doing
- Establish and maintain change control standards, templates, decision rights, and review cadences
- Coordinate change reviews across quality, CMC, supply chain, and external partners to align timelines
- Own and monitor change performance metrics including cycle time, aging, and quality indicators
- Ensure documentation traceability and inspection readiness from change initiation through closure
- Escalate high-risk or supply-impacting changes with mitigation plans and decision options
Privacy & handoff
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