Director of Development Quality & NPD

Madrigal Pharmaceuticals Italia; Conshohocken (Montgomery County); On-site; USD 212,000 - 240,000; Full time

Benefits offered by this job

Flexible paid time off

Medical

Dental

Vision & life/disability insurance

401(k) offerings

Supplemental life insurance

Legal services

Mental health benefits

Job summary

Madrigal Pharmaceuticals is seeking a senior QA leader to guide development quality strategy across the portfolio, ensuring phase-appropriate controls and governance across programs and modalities. You will establish operating model expectations, partner with CMC and clinical supply, and drive risk management, inspection readiness, and continuous improvement to accelerate safe, compliant development.

The ideal candidate has BS+ in life sciences or engineering, 12–15 years of QA leadership, and

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

Responsibilities

• Define development quality operating model, governance forums, and performance metrics, ensure consistent decision quality across programs
• Prioritize portfolio support and elevate resource, timeline, and quality risks with mitigation options
• Produce deliverables such as portfolio dashboards, governance calendars, and resourcing / risk briefs
• 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
• 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

Skills

Portfolio leadership

Executive influence

Quality risk management

eQMS proficiency

Change management

Education

BS+ Life Sciences / Engineering

Tools

Veeva Vault Quality

Job description

Madrigal Pharmaceuticals is seeking a senior QA leader to guide development quality strategy across the portfolio, ensuring phase-appropriate controls and governance across programs and modalities. You will establish operating model expectations, partner with CMC and clinical supply, and drive risk management, inspection readiness, and continuous improvement to accelerate safe, compliant development.

The ideal candidate has BS+ in life sciences or engineering, 12–15 years of QA leadership, and