Associate Director, API Quality Assurance – GMP

Madrigal Pharmaceuticals

Associate Director overseeing GMP API Quality Assurance at Madrigal Pharmaceuticals. Leading compliance and quality oversight for active pharmaceutical ingredient manufacturing.

Posted 7/25/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $169,000 - $198,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GMP API Quality Assurance, ensuring compliance with ICH Q7 and global regulatory standards while managing external API manufacturers. Proven ability to lead quality oversight, drive deviation assessments, and maintain quality agreements with CMOs.

Highest-signal resume keywords

GMP Pharmaceutical ExperienceAPI Quality OversightICH Q7 ComplianceRegulatory Knowledge (FDA, EMA)Change Control Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Assurance StrategyBatch Record ReviewDeviation Impact AssessmentRoot Cause Analysis (RCA)Corrective and Preventive Action (CAPA)Performance GovernanceDocumentation RigorAPI Specifications ManagementQuality Agreements MaintenanceKPI Development

Industry Keywords

API ManufacturingCMO OversightPharmaceutical ComplianceBiotech StandardsQuality ControlHealth Authority InspectionsGlobal Regulatory ExpectationsPerformance ScorecardsQuality Business Reviews (QBRs)Scientific Discipline (Chemistry, Chemical Engineering, Pharmacy)

About the role

Key responsibilities & impact

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)

Requirements

What you’ll need

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
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

Benefits

Comp & perks

Comprehensive benefits, including flexible paid time off
Medical, dental, vision and life/disability insurance
401(k) offerings (traditional, Roth, and employer match)
Additional voluntary benefits like supplemental life insurance and legal services
Mental health benefits through Employee Assistance Program for employees and their family