Director, Quality – New Product Development Lead
Madrigal Pharmaceuticals · Conshohocken, PA · Yesterday
Marketing$212k–$240k/yrFull-time
Key Responsibilities
- Portfolio Leadership & Operating Model
- Define development quality operating model, governance forums, and performance metrics
- Ensure consistent decision quality across programs
- Prioritize portfolio support and escalate resource, timeline, and quality risks with mitigation options
- Produce deliverables such as portfolio dashboards, governance calendars, and resourcing / risk briefs
- Development Oversight & Partner Governance
- Ensure phase-appropriate QMS application and documentation traceability across programs and external partners
- Set expectations for vendor oversight, audits, issue management, and readiness deliverables
- Produce deliverables such as vendor oversight standards, audit strategies, and readiness playbooks
- Inspection Readiness & Continuous Improvement
- Maintain readiness for development inspections and submission support
- Ensure narratives and evidence are current and retrievable
- Sponsor CI initiatives to improve cycle time, RFT documentation, and predictable execution across the portfolio
- Produce deliverables such as inspection readiness plans, evidence indexes, and CI roadmaps / benefits trackers
Required Qualifications
- BS+ Life Sciences / Engineering (or related)
- 12–15 years QA experience with significant development portfolio leadership experience
- Demonstrated people leadership and executive stakeholder influence
Preferred Qualifications
- Experience in pharmaceutical / biotech across multiple modalities and external development networks (preferred)
- Experience supporting inspections and major submissions / filings readiness