Senior Director, Product Quality Lead – Post-Marketing, Pharmacovigilance

🕒 April 30

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $244k - $299k / year

⏰ Full Time

🟠 Senior

🎡 Marketing

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• 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