Associate Director, Clinical Quality Assurance

📋 Description

• Lead the development, implementation, and maintenance of GCP quality assurance programs, policies
• Serve as the primary GCP quality assurance expert and point of contact, providing guidance on
• Ensure clinical programs comply with global health authority regulations, including relevant FDA
• Provide quality oversight and review of clinical trial documentation, including protocols, informed
• Monitor evolving GCP regulations and industry guidance, assess their impact on clinical operations
• Develop and execute global, risk-based audit strategies and annual audit plans, covering

🎯 Requirements

• Bachelor's degree or higher in Life Sciences, Chemistry, Pharmacy, or a related scientific
• Between 8 and 10 years of experience in pharmaceutical quality roles, ideally with substantial
• Demonstrated knowledge of global clinical research regulations, ICH GCP guidelines, health
• Experience using document control and quality management systems, such as ZenQMS, Veeva Vault, or
• Practical experience with GCP audits, including audit planning, execution, reporting, CAPA
• Familiarity with regulatory inspection preparation and support, including interactions involving

🎁 Benefits

• Competitive annual base salary: $117,000–$189,200, depending on qualifications, experience, skills
• Performance-based bonus: Eligible full-time employees may receive an annual company bonus based
• Retirement benefits: Eligibility to participate in a company-sponsored 401(k) plan and pension
• Comprehensive healthcare coverage: Eligible employees can access medical, dental, vision, and
• Paid time off: Vacation benefits and access to certain leave programs.
• Flexible benefits: Options may include healthcare and dependent care benefits, subject to