Senior GCP QA & Clinical Quality Leader

Madrigal; Pennsylvania; Hybrid; USD 147.000 - 180.000; Vollzeit

Benefits dieser Stelle

Equity

Comprehensive benefits

Flexible PTO

Medical/Dental/Vision/Life

401(k) with employer match

Zusammenfassung

Madrigal is seeking an experienced GCP Quality Assurance professional to ensure the quality and compliance of Madrigal-sponsored clinical trials across global regulators. You will lead audits, CAPA programs, and eQMS activities, partnering with cross-functional teams to uphold patient safety and data integrity.

Responsibilities include coordinating internal/external audits, managing quality events, and guiding inspection readiness.

Qualifikationen

• 7+ years of clinical quality assurance experience in biopharma/CRO
• Experience auditing clinical trial vendors/sites/TMFs
• GCP knowledge and familiarity with FDA/EMA regulations
• BS in science or equivalent work experience; certifications a plus

Aufgaben

• Develop and maintain quality systems to ensure GCP compliance
• Oversee audits and inspections (internal/external) and manage CAPA processes
• Coordinate cross-functional activities to embed quality culture
• Review and approve quality documents, contracts, and study documents
• Monitor regulatory changes and advise on impact to trials
• Mentor team members and support inspection readiness
• Collaborate with vendors to ensure adherence to quality agreements

Kenntnisse

GCP knowledge

QA auditing

Cross-functional collaboration

Regulatory compliance

Ausbildung

BS in science or equivalent

Tools

eQMS (Veeva)

Jobbeschreibung

Madrigal is seeking an experienced GCP Quality Assurance professional to ensure the quality and compliance of Madrigal-sponsored clinical trials across global regulators. You will lead audits, CAPA programs, and eQMS activities, partnering with cross-functional teams to uphold patient safety and data integrity.

Responsibilities include coordinating internal/external audits, managing quality events, and guiding inspection readiness.