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Senior Director, Clinical Supply Release
Madrigal PharmaceuticalsSenior Director overseeing QA disposition and clinical supply release for Madrigal, a biopharmaceutical company developing MASH therapeutics. Ensuring compliant operations, inspection readiness, and vendor governance.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in GMP QA and clinical supply release, ensuring compliance and documentation rigor while managing cross-functional coordination and external vendor oversight. Proficient in risk-based assessments and maintaining audit-ready documentation for GxP inspections.
Highest-signal resume keywords
GMP QA/Release ExperienceClinical Supply Chain ManagementVeeva Vault Quality (eQMS)Cross-Functional CoordinationRisk-Based Assessment
ATS Keywords
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Hard Skills
Clinical Supply Release GovernanceBatch/Packaging Record ReviewDocumentation StandardsCycle-Time ManagementDeviations CoordinationChange Control ManagementInspection-Readiness Evidence QualityLabeling/Packaging ReadinessRisk-Based EscalationQuality Event Management
Soft Skills
Strong Documentation DisciplineCross-Functional LeadershipExecutive-Ready Communication
Industry Keywords
GxP InspectionsClinical TrialsPharmaceuticalBiotechExternal Clinical Vendors
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Own QA disposition and release of clinical supplies to support trial timelines while ensuring compliant, traceable execution
- Ensure batch and packaging record completeness, labelling readiness, and release criteria execution for investigational products and clinical supply operations
- Coordinate with Clinical Ops, CMC, Supply Chain, and external vendors to manage priorities and reduce release bottlenecks
- Oversee deviations, investigations, and change controls impacting clinical release timelines with risk-based assessment and documentation rigor
- Maintain inspection readiness through audit-ready clinical supply release documentation and governance
- Own release criteria, checklists, and documentation standards and drive consistent, compliant disposition decisions
- Drive cycle-time and right-first-time improvements for clinical release workflows
- Produce release checklists, release dashboards, and clinical release cycle-time reports
- Ensure QA oversight over clinical packaging runs
- Coordinate deviations, investigations, and change controls, ensuring timely risk assessments and action closure
- Partner with Clinical Ops and Supply Chain on release schedules, priorities, and mitigation plans
- Produce release risk summaries, issue/action logs, and escalation briefs
- Maintain audit-ready release documentation and evidence packages and support GxP inspections
- Oversee external clinical vendors as applicable and ensure compliance with labelling and packaging expectations
- Produce inspection-ready evidence indexes and vendor oversight packs
Requirements
What you’ll need- BS+ in Science, Engineering, or related field
- 15+ years of GMP QA/release experience, with clinical supply experience strongly relevant
- Strong documentation discipline
- Strong cross-functional coordination capability
- Ability to travel 20–30% domestically and internationally
- Experience in pharmaceutical or biotech clinical supply chains preferred
- Experience with IMP labelling/packaging preferred
- Experience with external clinical vendors preferred
- Experience supporting GxP inspections involving clinical supply release activities
- Proficiency with Veeva Vault Quality (eQMS) to manage clinical release documentation and quality events impacting timelines
- Knowledge of clinical supply release governance, batch/packaging record review, and disposition decision-making
- Knowledge of cycle-time management, labelling/packaging readiness, controlled documentation, and inspection-readiness evidence quality
- Experience coordinating deviations, investigations, and change controls for clinical timelines
- Ability to perform risk-based escalation and action closure
- Partner governance and performance management across external clinical vendors
- Cross-functional leadership, escalation, and executive-ready risk/decision communication
Benefits
Comp & perks- Equity for all employees
- Flexible paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- Life/disability insurance
- 401(k) traditional, Roth, and employer match offerings
- Supplemental life insurance
- Legal services
- Mental health benefits through the Employee Assistance Program for employees and their family
- Reasonable accommodations throughout the hiring process