Quality Compliance Director

The Senior Director of Quality & Compliance will lead GCP QA programs to ensure compliance with FDA, EMA, and ICH regulations. This role involves providing guidance across the clinical development life cycle and overseeing quality initiatives.

Key Responsibilities

• Lead GCP QA programs for FDA/EMA/ICH compliance
• Provide ICH/GCP guidance throughout the clinical development life cycle
• Plan and conduct GCP audits of vendors, sites, and TMF
• Manage Quality Management Systems (QMS), Standard Operating Procedures (SOPs), training, and Corrective Action Preventive Actions (CAPAs)
• Offer cross-functional compliance guidance and strategic advice
• Lead and develop Clinical QA staff and support quality initiatives

Requirements & Qualifications

• 10+ years of experience in GCP QA within CRO, biotech, or pharma
• Bachelor's degree in life sciences; advanced degree preferred
• Experience leading GCP audits across sites, TMF, and vendor qualification
• Strong knowledge of FDA, EMA, and ICH regulations and global GCP
• Experience supporting regulatory inspections and ensuring inspection readiness
• Ability to translate regulatory requirements into effective quality systems and risk-based processes