Senior Manager, Deviation Management – Quality Assurance

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 metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR‑β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high‑performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

Owns deviation management governance to ensure deviations are triaged, investigated, and closed in a timely, compliant, and high‑quality manner. Establishes standards for investigation rigor, root cause analysis, impact assessment, and linkage to CAPA and change control. Drives performance management (cycle time, backlog, aging) and trending to reduce recurrence and protect compliance and supply. Maintains inspection readiness through consistent documentation practices and governance routines across internal and external partners as applicable. Coaches teams on investigation quality expectations and effective prevention actions.

Key Responsibilities

• Process Ownership & Governance – Own deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation). Ensure consistent severity classification and impact assessment expectations across teams / sites / partners. Produce deliverables such as deviation governance playbooks, triage guides, and KPI dashboards.
• Investigation Quality & CAPA Linkage – Drive RCA rigor and evidence standards, coach investigators and ensure high‑quality conclusions and documentation. Ensure CAPA linkage, effectiveness checks, and recurrence prevention are implemented and verified. Produce deliverables such as investigation quality checklists, CAPA linkage reports, and effectiveness review summaries.
• Trending & Inspection Readiness – Own deviation trending and management review inputs, identify systemic themes and drive cross‑functional actions. Maintain inspection‑ready deviation records and process narratives, support audits / inspections and responses. Produce deliverables such as trend reports, management review packs, and inspection‑ready narratives.

Required Qualifications

• BS+ in Science / Engineering (or related)
• 7–10 years in GMP QA / QMS with strong deviation / investigation leadership experience
• Demonstrated improvements in cycle time, investigation quality, and recurrence reduction

Preferred Qualifications

• Experience in pharmaceutical / biotech external manufacturing networks and partner deviation governance (preferred)
• Experience with eQMS workflows and continuous improvement / problem‑solving facilitation

Key Competencies

• Deviation governance, investigation quality standards, and cycle‑time / backlog management, escalation, and action closure discipline
• RCA facilitation, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights
• Partner governance and performance management across sites / CMOs for deviation quality and responsiveness (as applicable)
• Cross‑functional leadership, escalation, and executive‑ready risk / decision communication
• Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness
• Veeva Vault Quality (eQMS) proficiency to drive deviation workflow execution, CAPA linkage, and trending

Total Rewards & Benefits

Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $147,600 - $180,400 per year. We comply with all applicable minimum wage laws. All full‑time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create.

Full‑time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process.

Equal Opportunity Employer

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.