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 Director, Product Quality Lead – Post-Marketing, Pharmacovigilance
🕒 April 30
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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
• Lead and mature our global PV Quality function • Provide strategic direction and operational Quality leadership in pharmacovigilance activities • Partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial teams • Shape risk-based PV QA systems, and mentor a team committed to patient safety practices • Establish product-specific quality strategies and maintain inspection readiness • Support rapid response to product quality concerns
🎯 Requirements
• Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline • 12+ years in pharmaceutical or biopharmaceutical industry, including significant experience in post-marketing PV QA • At least 5 years in QA (GVP and GMP) • Proven experience leading and supporting regulatory inspections (FDA, EMA, MHRA, etc.) and implementing CAPAs • Strong understanding of ICH, GVP Modules, FDA 21 CFR, EU PV requirements, EU Vol4
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible paid time off • Medical, dental, and vision insurance • Life/disability insurance • Mental health benefits through Employee Assistance Program • Additional voluntary benefits like supplemental life insurance and legal services
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