Associate Director, Research Quality Assurance

Role: Associate Director of Research and Development Quality Assurance, providing technical leadership in compliance for clinical development, medical affairs, drug safety, and nonclinical programs. Responsibilities: develop and execute audit strategies for GCP, GPP, GLP, and GVP; oversee audits, ensure inspection readiness, and support regulatory agency inspections; identify and mitigate compliance risks; collaborate with internal teams and external auditors; drive continuous improvement of quality systems; manage audit reports and corrective actions; support vendor qualification and internal audits. Requirements: Bachelor's in life sciences; 8+ years in GCP/GLP compliance and auditing; strong knowledge of FDA, EMA, MHRA regulations, ICH guidelines, and clinical trial directives; leadership and project management skills; excellent communication and technical writing. Preferred: broad experience across product development, clinical operations, and regulatory compliance; international regulatory knowledge; ability to influence and manage cross-functional teams; domestic and international travel (~15%). High-value: focus on GCP, GLP, GVP audits, regulatory inspection support, extensive compliance expertise, and leadership in quality assurance within biopharma clinical trial settings.