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.

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 and 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

Key Competencies
- Development QA governance, phase-appropriate oversight, and readiness milestone management
- Change management (impact assessment, stakeholder mapping, communications, training/SOP readiness, adoption measurement)
- Partner governance/performance management across CMOs/vendors; inspection readiness evidence discipline
- Cross-functional leadership, escalation, and executive-ready risk/decision communication
- Quality risk management, issue triage, and timely action closure
- Veeva Vault Quality (eQMS) proficiency

Benefits
- Flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) offerings; supplemental voluntary benefits; mental health benefits via Employee Assistance Program.

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