Development QA Lead - Oral Programs

Madrigal Pharmaceuticals; Waltham (MA); Vor Ort; USD 169.000 - 198.000; Vollzeit

Benefits dieser Stelle

Equity

Flexible PTO

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life/disability insurance

Mental health benefits

Employee Assistance Program

Zusammenfassung

Madrigal Pharmaceuticals is seeking a Senior Quality leader to own the quality strategy for oral development programs, ensuring phase-appropriate oversight and compliant execution across internal and external teams.

You will partner with CMC and clinical supply stakeholders on control strategies, tech transfer readiness, and issue management to enable efficient progression toward commercialization while maintaining compliance.

Qualifikationen

• BS+ Life Sciences / Engineering (or related)
• 10–12 years QA experience with development-stage oversight
• Demonstrated cross-functional leadership and risk-based judgment
• Experience in pharmaceutical / biotech oral product development and clinical supply interfaces (preferred)
• Experience with external development networks and inspection support

Aufgaben

• 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
• Oversee external vendors / CMOs supporting oral development activities as applicable, 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

Kenntnisse

Cross-functional leadership

Risk assessment

Quality systems (QMS)

Ausbildung

BS Life Sciences / Engineering

Tools

Veeva Vault Quality (eQMS)

Jobbeschreibung

Madrigal Pharmaceuticals is seeking a Senior Quality leader to own the quality strategy for oral development programs, ensuring phase-appropriate oversight and compliant execution across internal and external teams.

You will partner with CMC and clinical supply stakeholders on control strategies, tech transfer readiness, and issue management to enable efficient progression toward commercialization while maintaining compliance.