Associate Director, API Quality Assurance (GMP)

Madrigal; Pennsylvania; Hybrid; USD 169,000 - 198,000; Full time

Benefits offered by this job

Flexible paid time off

Medical

Dental

Vision and life/disability insurance

401(k) offerings (i.e., traditional, 2

Supplemental life insurance

Legal services

Other offerings

Mental health benefits

Job summary

Madrigal is seeking a senior QA leader to oversee GMP API Quality Assurance and external partner oversight across CMOs/CDMOs. You will ensure ICH Q7 compliance, drive deviation/CAPA, and manage API batch documentation with strong risk-based controls.

Lead a cross-functional team, mentor API QA staff, and support health authority inspections. This role offers a comprehensive benefits package and equity opportunities.

Qualifications

• BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related)
• 10-12 years GMP pharmaceutical/biotech experience with significant focus on API quality and CMO oversight
• Demonstrated leadership in API batch disposition, deviation/CAPA, and change control governance
• Strong knowledge of ICH Q7, ICH Q8-Q11, FDA, EMA, and global API regulatory expectations
• Proven track record managing external API manufacturers and supporting health authority inspections

Responsibilities

• Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers
• Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance
• Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability
• Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events
• Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes
• Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs)
• Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners
• Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes
• Lead inspection readiness for API operations, including documentation, evidence packages, and audit response narratives
• Support FDA, EMA, and other health authority inspections related to API manufacturing and partner audits
• Drive trending and recurrence prevention for API quality events; deliver management review-ready insights
• Lead and mentor API QA staff and provide quality input on cross-functional governance forums

Skills

API quality governance

External partner oversight

ICH Q7 compliance

Inspection readiness

CAPA management

Education

BS or MSc in a scientific discipline

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.

Leads GMP API Quality Assurance to ensure compliant, risk-based oversight of active pharmaceutical ingredient (API) and intermediate manufacturing across external CMOs/CDMOs. Owns API-specific quality strategy, governance cadence, and performance management to enable predictable supply and consistent compliance with ICH Q7 and global health authority expectations. Establishes standards for API batch documentation review, deviation and change control management, and partner performance trending. Partners with MSAT, Supply Chain, Regulatory, and CMOs on tech transfer readiness, control strategy evolution, and lifecycle management of commercial APIs. Maintains inspection readiness through robust documentation control, evidence packages, and decision rationale traceability.

Key Responsibilities

• Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers
• Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance
• Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability
• Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events
• Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes
• Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs)
• Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners
• Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes
• Lead inspection readiness for API operations, including documentation, evidence packages, and audit response narratives
• Support FDA, EMA, and other health authority inspections related to API manufacturing and partner audits
• Drive trending and recurrence prevention for API quality events; deliver management review-ready insights
• Lead and mentor API QA staff and provide quality input on cross-functional governance forums

Required Qualifications

• BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related)
• 10-12 years of GMP pharmaceutical/biotech experience with significant focus on API quality and CMO oversight
• Demonstrated leadership in API batch disposition, deviation/CAPA, and change control governance
• Strong knowledge of ICH Q7, ICH Q8-Q11, FDA, EMA, and global API regulatory expectations
• Proven track record managing external API manufacturers and supporting health authority inspections

Preferred Qualifications

• Advanced degree (MS/PhD) and experience with small molecule API and/or oligonucleotide manufacturing
• Experience supporting tech transfers, validation, and post-approval change management at API CMOs
• Experience with Veeva Vault Quality (eQMS) and quality metrics/trending for API operations
• Experience in pharmaceutical / biotech external manufacturing networks (preferred)

Key Competencies

• API quality governance, ICH Q7 compliance interpretation, and risk-based oversight discipline
• External partner oversight, quality agreements, and performance management across API CMOs/CDMOs
• Deviation impact assessment, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights
• Change control governance and risk-based impact assessment for API processes, specifications, and methods
• 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 manage API quality events, partner oversight, and inspection-ready evidence

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. 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 $169,000-$198,000 per year. We comply with all applicable minimum wage laws.

Full-time employees are also eligible for comprehensive benefits listed below.

• Flexible paid time off
• Medical
• Dental
• Vision and life/disability insurance
• 401(k) offerings (i.e., traditional, Roth, and employer match)

Additional voluntary benefits include:

• Supplemental life insurance
• Legal services
• 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. If you need assistance, please contact [e-mail].

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.