Remote Senior GCP QA Lead

Regulatory Jobs; Pennsylvania; Remote; USD 147,000 - 180,000; Full time

Benefits offered by this job

Equity

Bonus

401(k) Plan

Medical Insurance

Dental Insurance

Job summary

Madrigal is seeking a qualified GCP Quality Assurance professional to lead clinical quality activities ensuring GCP compliance for Madrigal-sponsored trials across global programs.

Reporting to the Senior Director, GCP Quality, you will oversee risk-based quality systems, vendor audits, CAPAs, and inspections, partnering with cross-functional teams to advance patient safety and data integrity. Competitive compensation and comprehensive benefits are offered.

Qualifications

• Minimum 7 years of clinical quality assurance experience within biopharma or CRO, including auditing of trial vendors/sites/TMFs or internal R&D processes.
• Minimum 3–5 years in a clinical operations role at a CRO or sponsor, including cross-functional study management.
• Experience in inspection preparation and/or supporting health authority inspections is a plus.
• Demonstrated GCP knowledge; GVP/GLP knowledge or certifications are a plus.

Responsibilities

• Develop and maintain clinical quality systems to ensure compliance with ICH GCP, FDA, EMA, and global regulations.
• Ensure R&D trials are compliant with applicable guidelines and country regulations.
• Lead quality investigations and CAPAs through to closure.
• Support inspections readiness and global agency inspections as needed.
• Mentor team members and contribute to process improvements.

Skills

GCP Knowledge

Quality Assurance

Regulatory Compliance

Auditing

Cross-functional Collaboration

Education

BS in Life Sciences

Tools

Veeva eQMS

Job description

Madrigal is seeking a qualified GCP Quality Assurance professional to lead clinical quality activities ensuring GCP compliance for Madrigal-sponsored trials across global programs.

Reporting to the Senior Director, GCP Quality, you will oversee risk-based quality systems, vendor audits, CAPAs, and inspections, partnering with cross-functional teams to advance patient safety and data integrity. Competitive compensation and comprehensive benefits are offered.