Executive Director, Development Quality Lead
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Conshohocken, PA)
United States
Operations
Provides phase-appropriate Quality Assurance leadership for development activities, embedding quality planning and risk management into execution; establishes governance for development quality oversight; ensures development documentation is traceable, controlled, and inspection ready; partners with CMC and clinical supply stakeholders on control strategy evolution, readiness milestones, and tech transfer/scale-up planning; guides QMS processes (deviations, CAPA, change control) in development contexts; oversees development partners/vendors and drives issue resolution and compliance readiness.
Key Responsibilities
- Define phase-appropriate QA oversight model and governance cadence; embed risk management into development execution; produce program quality plans, risk registers, and readiness milestone trackers.
- Guide deviations/CAPA/change control expectations for development activities; support tech transfer and scale-up readiness planning; produce governance packs, decision logs, and readiness checklists.
- Oversee partners/vendors as applicable; maintain inspection readiness plans, evidence packages, and development quality training/standards; produce vendor oversight plans, audit schedules, and inspection-ready evidence indexes.
Required Qualifications
- BS+ (Life Science, Engineering, or related)
- 18+ years QA (development/tech ops preferred) with governance and audit support experience
- Demonstrated cross-functional leadership and risk-based judgment
Preferred Qualifications
- Pharmaceutical/biotech development quality experience supporting inspections/submission readiness
- Experience overseeing CRO/CMO development partners
Key Competencies
- Development QA governance and readiness milestone management; documentation traceability
- Quality risk management; deviation/CAPA/change control application
- Partner/vendor oversight; audit readiness planning; issue escalation/follow-through
- Executive-ready risk/decision communication
- Control strategy evolution with CMC/clinical supply; tech transfer/scale-up alignment
- Veeva Vault Quality (eQMS) proficiency
Application instructions: Submit via Madrigal Careers site.
Key Responsibilities
- Define phase-appropriate QA oversight model and governance cadence; embed risk management into development execution; produce program quality plans, risk registers, and readiness milestone trackers.
- Guide deviations/CAPA/change control expectations for development activities; support tech transfer and scale-up readiness planning; produce governance packs, decision logs, and readiness checklists.
- Oversee partners/vendors as applicable; maintain inspection readiness plans, evidence packages, and development quality training/standards; produce vendor oversight plans, audit schedules, and inspection-ready evidence indexes.
Required Qualifications
- BS+ (Life Science, Engineering, or related)
- 18+ years QA (development/tech ops preferred) with governance and audit support experience
- Demonstrated cross-functional leadership and risk-based judgment
Preferred Qualifications
- Pharmaceutical/biotech development quality experience supporting inspections/submission readiness
- Experience overseeing CRO/CMO development partners
Key Competencies
- Development QA governance and readiness milestone management; documentation traceability
- Quality risk management; deviation/CAPA/change control application
- Partner/vendor oversight; audit readiness planning; issue escalation/follow-through
- Executive-ready risk/decision communication
- Control strategy evolution with CMC/clinical supply; tech transfer/scale-up alignment
- Veeva Vault Quality (eQMS) proficiency
Application instructions: Submit via Madrigal Careers site.