Associate Director, Quality Change Management
Madrigal Pharmaceuticals
August 16, 2026
Remote friendly (Conshohocken, PA)
United States
Corporate Functions
Leads Quality change control governance to ensure changes are risk-assessed, compliant, and implemented with appropriate controls across internal operations and external partners. Aligns stakeholders on impact assessment, readiness criteria, and documentation expectations. Partners with CMC/MSAT, Supply Chain, Operations, and Quality for tech transfers, validation readiness, and lifecycle changes. Owns change performance metrics (cycle time, aging, quality) and drives continuous improvement. Ensures inspection-ready traceability from change initiation through closure.
Key Responsibilities
- Own change control standards, templates, decision rights, and review cadences; ensure consistent risk-based assessments.
- Define implementation readiness criteria, verification expectations, and closure quality standards.
- Coordinate change reviews across Quality/CMC/MSAT/Supply Chain and external partners; align timelines/dependencies; escalate high-risk or supply-impacting changes.
- Own change KPIs and inspection-ready documentation, traceability, and evidence retrieval.
Required Qualifications
- BS+ in Science/Engineering (or related).
- 10–12 years GMP QA/QMS with change control leadership experience.
- Demonstrated ability to lead cross-functional governance and risk-based decision making.
Preferred Qualifications
- Post-approval change governance and external manufacturing change experience.
- eQMS configuration and workflow optimization.
Key Competencies
- Risk-based impact assessment, implementation readiness, predictable throughput, cross-functional leadership, escalation, change management, partner governance, inspection readiness traceability, and Veeva Vault Quality (eQMS) proficiency.
Benefits (explicitly stated)
- Base pay range: $164,000–$200,750/year; equity; flexible paid time off; medical/dental/vision; life/disability; 401(k) match; additional voluntary benefits.
Application Instructions
- Submit via the Madrigal Careers site on an ongoing basis.
Key Responsibilities
- Own change control standards, templates, decision rights, and review cadences; ensure consistent risk-based assessments.
- Define implementation readiness criteria, verification expectations, and closure quality standards.
- Coordinate change reviews across Quality/CMC/MSAT/Supply Chain and external partners; align timelines/dependencies; escalate high-risk or supply-impacting changes.
- Own change KPIs and inspection-ready documentation, traceability, and evidence retrieval.
Required Qualifications
- BS+ in Science/Engineering (or related).
- 10–12 years GMP QA/QMS with change control leadership experience.
- Demonstrated ability to lead cross-functional governance and risk-based decision making.
Preferred Qualifications
- Post-approval change governance and external manufacturing change experience.
- eQMS configuration and workflow optimization.
Key Competencies
- Risk-based impact assessment, implementation readiness, predictable throughput, cross-functional leadership, escalation, change management, partner governance, inspection readiness traceability, and Veeva Vault Quality (eQMS) proficiency.
Benefits (explicitly stated)
- Base pay range: $164,000–$200,750/year; equity; flexible paid time off; medical/dental/vision; life/disability; 401(k) match; additional voluntary benefits.
Application Instructions
- Submit via the Madrigal Careers site on an ongoing basis.