Associate Director, Development Quality – OSD

Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones; ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports progression toward commercialization while maintaining compliance and predictable execution.

Key Responsibilities
- Program QA Leadership (Oral)
- Own quality strategy, governance cadence, and risk register for assigned oral programs; define and track readiness milestones
- Guide application of QMS processes (deviations/CAPA/change control) in development context; ensure timely closure
- Produce deliverables such as program quality plans, readiness trackers, and decision/action logs
- Partner Oversight & Inspection Readiness
- Oversee external vendors/CMOs supporting oral development activities; ensure governance and escalation pathways
- Maintain inspection-ready documentation, narratives, and evidence packages for program scope
- Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes

Required Qualifications
- BS+ Life Sciences/Engineering (or related)
- 10–12 years QA experience with development-stage oversight
- Demonstrated cross-functional leadership and risk-based judgment

Preferred Qualifications
- Experience in pharmaceutical/biotech oral product development and clinical supply interfaces
- Experience with external development networks and inspection support

Application instructions
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).