Madrigal Pharmaceuticals
51 - 200 employees
💊 Pharmaceuticals
🧬 Biotechnology
⚕️ Healthcare Insurance
💰 $259M Post-IPO Equity on 2022-12
Pharmaceuticals • Biotechnology • Healthcare Insurance
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.
Senior Manager, GMP Quality Assurance
🕒 April 30
🔔 Pennsylvania – Remote
💵 147k - 180k / year
⏰ Full Time
🟠 Senior
🔧 QA Engineer (Quality Assurance)
🦅 H1B Visa Sponsor
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Madrigal Pharmaceuticals
51 - 200 employees
💊 Pharmaceuticals
🧬 Biotechnology
⚕️ Healthcare Insurance
💰 $259M Post-IPO Equity on 2022-12
Pharmaceuticals • Biotechnology • Healthcare Insurance
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
• Responsible for quality oversight of external GMP manufacturers • Serve as primary quality liaison across internal functions and external partners • Drive quality strategy and enable risk-based decision-making • Lead continuous improvement initiatives • Maintain inspection readiness through strong documentation control
🎯 Requirements
• BS or MSc in a scientific discipline • At least 7 years of experience in GMP pharmaceutical/biotech manufacturing • Experience managing commercial external manufacturers • QA review of batch documentation and quality events • Strong knowledge of Good Manufacturing Practices (GMPs) • Knowledge of FDA regulations and ICH Guidelines • Strong deviation impact assessment capability • Experience with Veeva Quality/Docs and Veeva QMS modules
🏖️ Benefits
• Health insurance • 401(k) matching • Paid time off • Remote work options • Mental health benefits
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