Associate Director, API Quality Assurance – GMP

🔥 30 minutes ago

🇺🇸 United States – Remote

💵 $169k - $198k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Madrigal Pharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $259M Post-IPO Equity on 2022-12

Healthcare • Pharmaceuticals • Biotechnology

Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.

📋 Description

• 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

• 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

• 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