QA Deviation & CAPA Excellence Lead

Madrigal; Pennsylvania; Hybrid; USD 148,000 - 180,000; Full time

Benefits offered by this job

Equity

Health benefits

401(k) match

Mental health support

Disability accommodation

Job summary

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for MASH. We are seeking a Senior QA/Deviation Governance Lead to own deviation governance, investigation quality, CAPA linkage, and trend analysis across sites and partners.

You will lead RCA rigor, ensure CAPA effectiveness, and maintain inspection readiness with cross‑functional teams. Required BS+ in Science/Engineering and 7–10 years of GMP QA/QMS experience; preference for eQMS (Veeva Vault) experience.

Qualifications

• 7–10 years in GMP QA / QMS with strong deviation / investigation leadership experience.
• Experience with eQMS workflows and continuous improvement / problem‑solving.
• Experience in pharmaceutical/biotech external manufacturing networks (preferred).

Responsibilities

• Process Ownership & Governance – Own deviation standards, templates, training expectations, and governance cadence.
• Investigation Quality & CAPA Linkage – Drive RCA rigor, ensure CAPA linkage and effectiveness checks.
• Trending & Inspection Readiness – Maintain deviation trending records and support audits/inspections.

Skills

GMP QA / QMS experience

Investigation leadership

RCA facilitation

CAPA linkage

Education

BS+ in Science / Engineering (or related)

Tools

Veeva Vault Quality (eQMS)

Job description

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for MASH. We are seeking a Senior QA/Deviation Governance Lead to own deviation governance, investigation quality, CAPA linkage, and trend analysis across sites and partners.

You will lead RCA rigor, ensure CAPA effectiveness, and maintain inspection readiness with cross‑functional teams. Required BS+ in Science/Engineering and 7–10 years of GMP QA/QMS experience; preference for eQMS (Veeva Vault) experience.