Senior Director, Project Quality

📋 Description

• Lead development and management of a company-wide Quality Management System (QMS).
• Oversee QMS reviews and electronic QMS solution across sites.
• Partner with site heads to maintain quality compliance processes.
• Establish and lead the Project Quality team, including staffing and training.
• Oversee quality management activities: plans, risk management, CAPA, and improvements.
• Collaborate to harmonize quality-related processes and SOPs.

🎯 Requirements

• Master’s degree or equivalent qualification.
• 8+ years in quality/compliance management within clinical research.
• Strong understanding of clinical research activities in hospital/clinic settings.
• Expert knowledge of QMS requirements and quality practices.
• Understanding of clinical research processes and site conduct.
• Expert-level knowledge of quality issue identification, triage, CAPA, risk assessment, and impact

🎁 Benefits

• Health, dental, and vision insurance plans.
• 401(k) with 100% employer match on first 4% of contributions.
• Tution reimbursement.
• Parental leave.
• Employee referral program.
• Employee assistance program.