Associate Director of GCP Quality Assurance

The Associate Director of GCP Quality Assurance will provide quality oversight and compliance support for Clinical Development and Pharmacovigilance activities related to biologic development clinical programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, as well as all applicable global regulatory standards.

Requirements

• Bachelor's degree with 9+ years of experience required OR Master's degree and 7+ years of experience PhD/JD and 5+ years of experience MD/DO and 1+ years of experience may be considered
• Relevant experience in Quality Assurance within Clinical Operations, preferably in biologics or biotechnology
• Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP Directive/Regulation, FDA GCP regulations, and international GVP standards
• Experience with CRO vendor oversight, including audits and inspections
• Familiarity with electronic systems for clinical data (e.g., EDC, CTMS, Argus, ARISg, Veeva Vault)
• Demonstrated success in managing quality issues, audits, and regulatory inspections
• Excellent communication, organizational, and interpersonal skills with the ability to influence and collaborate across functions and geographies

Benefits

• Medical, dental and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program