Senior Manager, GCP Quality Assurance

🕒 April 30

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $147k - $180k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Madrigal Pharmaceuticals

WebsiteLinkedInAll Job Openings

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 GCP/Clinical Quality Assurance activities • Ensure quality and compliance of Madrigal-sponsored clinical trials • Develop, implement, and/or maintain clinical quality systems and processes • Align organization to ICH in implementing a quality culture • Engage partnership with external clinical trial vendors • Conduct or manage internal/external audits • Lead reviews, manage documentation, and track Observations/Findings • Review key clinical program or study documents

🎯 Requirements

• Minimum 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry • Minimum 3-5 years of experience in a clinical operations role at a CRO or Sponsor • Experience in inspection preparation and/or supporting health authority/regulatory agency inspections • Demonstrated GCP knowledge • BS in a scientific or other relevant discipline with equivalent work experience

🏖️ Benefits

• Flexible paid time off • Medical insurance • Dental insurance • Vision insurance • Life/disability insurance • 401(k) offerings (traditional, Roth, employer match) • Supplemental life insurance • Legal services • Mental health benefits through Employee Assistance Program