Senior Manager, Deviation Management – Quality Assurance
Madrigal Pharmaceuticals · Conshohocken -, PA
QualityFull-time$148k–$180kCompany career page
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Role summary
Madrigal Pharmaceuticals seeks a Senior Manager of Deviation Management to establish and oversee governance frameworks ensuring timely, compliant investigation and closure of quality deviations. The role drives performance management, root cause analysis rigor, and inspection readiness across internal and external manufacturing partners.
What they're looking for
- Bachelor's degree in science, engineering, or related field
- 7–10 years of GMP quality assurance and quality management systems experience
- Demonstrated leadership in deviation management and investigation processes
- Proven track record reducing cycle time, improving investigation quality, and preventing recurrence
- Veeva Vault Quality (eQMS) proficiency
- Experience managing deviations across external manufacturing and contract manufacturing organizations (preferred)
- Cross-functional leadership and executive communication skills
What you'll be doing
- Establish and maintain deviation standards, templates, training curricula, and governance procedures
- Drive root cause analysis rigor, coach investigation teams, and ensure high-quality conclusions and documentation
- Manage deviation trending, identify systemic themes, and support management review and inspection readiness
- Ensure CAPA linkage, effectiveness verification, and recurrence prevention implementation across sites and partners
- Produce governance playbooks, triage guides, trend reports, and inspection-ready narratives
Privacy & handoff
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