Associate Director, GCP Quality Oversight

Job not on LinkedIn

🔥 12 minutes ago

🇺🇸 United States – Remote

💵 $165k - $201k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams. • Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity. • Oversees quality performance across a portfolio of programs and studies, ensuring measurable recurrence reduction. • Provides executive-ready reporting on quality risks, trends, and readiness. • May lead/mentor GCP quality staff.

🎯 Requirements

• Minimum 10 years in clinical quality assurance • Minimum 3 years experience in a clinical operations role at a CRO or Sponsor • Demonstrated experience conducting and/or overseeing vendor, investigator site, Document/TMF, and process audits. • BS+ in Life Sciences or related discipline (Preferred) • Experience leading global health authority inspection readiness and responses (e.g., FDA) across sponsor-led and outsourced models (Preferred) • Experience implementing/optimizing eQMS workflows and quality metrics frameworks for GCP oversight at scale; Veeva Quality a plus (Preferred)

🏖️ Benefits

• flexible paid time off • medical insurance • dental insurance • vision insurance • life insurance • disability insurance • 401(k) offerings (traditional, Roth, and employer match) • additional voluntary benefits like supplemental life insurance, legal services • mental health benefits through Employee Assistance Program