Senior Manager, Deviation Management – Quality Assurance
Madrigal Pharmaceuticals
August 16, 2026
Remote friendly (Conshohocken, PA)
United States
Operations
Key Responsibilities
- Own deviation management governance to ensure deviations are triaged, investigated, and closed timely, compliant, and high-quality.
- Establish standards for investigation rigor, root cause analysis (RCA), impact assessment, and linkage to CAPA and change control.
- Drive performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply.
- Maintain inspection readiness via consistent documentation practices and governance across internal/external partners.
- Coach teams on investigation quality expectations and prevention actions.
Process Ownership & Governance
- Own deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation).
- Ensure consistent severity classification and impact assessment across teams/sites/partners.
- Create deliverables: deviation governance playbooks, triage guides, KPI dashboards.
Investigation Quality & CAPA Linkage
- Drive RCA rigor and evidence standards; ensure high-quality conclusions/documentation.
- Ensure CAPA linkage, effectiveness checks, and recurrence prevention are implemented/verified.
- Create deliverables: investigation quality checklists, CAPA linkage reports, effectiveness review summaries.
Trending & Inspection Readiness
- Own deviation trending and management review inputs; identify systemic themes and drive cross-functional actions.
- Maintain inspection-ready records/process narratives; support audits/inspections.
- Create deliverables: trend reports, management review packs, inspection-ready narratives.
Required Qualifications
- BS+ in Science/Engineering (or related).
- 7–10 years in GMP QA/QMS with strong deviation/investigation leadership.
- Demonstrated improvements in cycle time, investigation quality, and recurrence reduction.
Preferred Qualifications
- Experience in pharmaceutical/biotech external manufacturing networks and partner deviation governance.
- Experience with eQMS workflows and continuous improvement/problem-solving facilitation.
Benefits (full-time)
- Flexible paid time off; medical, dental, vision; life/disability insurance; 401(k) offerings; supplemental voluntary benefits; Employee Assistance Program.
Application Instructions
- Submit through the Madrigal Careers site (applications accepted on an ongoing basis).
- Own deviation management governance to ensure deviations are triaged, investigated, and closed timely, compliant, and high-quality.
- Establish standards for investigation rigor, root cause analysis (RCA), impact assessment, and linkage to CAPA and change control.
- Drive performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply.
- Maintain inspection readiness via consistent documentation practices and governance across internal/external partners.
- Coach teams on investigation quality expectations and prevention actions.
Process Ownership & Governance
- Own deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation).
- Ensure consistent severity classification and impact assessment across teams/sites/partners.
- Create deliverables: deviation governance playbooks, triage guides, KPI dashboards.
Investigation Quality & CAPA Linkage
- Drive RCA rigor and evidence standards; ensure high-quality conclusions/documentation.
- Ensure CAPA linkage, effectiveness checks, and recurrence prevention are implemented/verified.
- Create deliverables: investigation quality checklists, CAPA linkage reports, effectiveness review summaries.
Trending & Inspection Readiness
- Own deviation trending and management review inputs; identify systemic themes and drive cross-functional actions.
- Maintain inspection-ready records/process narratives; support audits/inspections.
- Create deliverables: trend reports, management review packs, inspection-ready narratives.
Required Qualifications
- BS+ in Science/Engineering (or related).
- 7–10 years in GMP QA/QMS with strong deviation/investigation leadership.
- Demonstrated improvements in cycle time, investigation quality, and recurrence reduction.
Preferred Qualifications
- Experience in pharmaceutical/biotech external manufacturing networks and partner deviation governance.
- Experience with eQMS workflows and continuous improvement/problem-solving facilitation.
Benefits (full-time)
- Flexible paid time off; medical, dental, vision; life/disability insurance; 401(k) offerings; supplemental voluntary benefits; Employee Assistance Program.
Application Instructions
- Submit through the Madrigal Careers site (applications accepted on an ongoing basis).