Senior QA Leader – Oral Development Programs

Regulatory Jobs; Conshohocken (Montgomery County); Presencial; USD 169.000 - 198.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

flexible paid time off

medical

dental

vision

life/disability insurance

401(k) offerings

equity ownership

Descripción de la vacante

Madrigal is seeking a Program QA Leader (Oral) to drive quality strategy across development programs for our MASH portfolio. You will own governance, readiness milestones, and risk management, ensuring inspection-ready documentation and compliance across internal teams and CMOs.

The ideal candidate has BS+ in Life Sciences or Engineering, 10–12 years of development QA experience, and a proven ability to lead cross-functional teams.

Formación

• 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

Responsabilidades

• Own quality strategy, governance cadence, and readiness milestones for oral programs
• Guide application of QMS processes (deviations / CAPA / change control) in development context
• Produce deliverables such as program quality plans, readiness trackers, and decision / action logs
• Oversee external vendors / CMOs supporting oral development activities and ensure governance
• Maintain inspection-ready documentation, narratives, and evidence packages

Conocimientos

QA leadership

Cross-functional leadership

Risk-based judgment

External development networks

Inspection support

Educación

BS+ Life Sciences / Engineering (or related)

Herramientas

Veeva Vault Quality (eQMS)

Descripción del empleo

Madrigal is seeking a Program QA Leader (Oral) to drive quality strategy across development programs for our MASH portfolio. You will own governance, readiness milestones, and risk management, ensuring inspection-ready documentation and compliance across internal teams and CMOs.

The ideal candidate has BS+ in Life Sciences or Engineering, 10–12 years of development QA experience, and a proven ability to lead cross-functional teams.