Associate Director, Clinical Quality Assurance

Role: Associate Director of Clinical Quality Assurance overseeing clinical development programs at EyePoint. Responsibilities include leading and improving the QMS, ensuring GCP compliance, managing audit programs of clinical sites and documents, supporting inspection readiness, and collaborating with Clinical Operations, Biometrics, and Pharmacovigilance teams. The role involves risk assessment, vendor evaluation, and quality metrics tracking to foster continuous GCP adherence. Requirements: Bachelor's or advanced degree in a scientific discipline, minimum 10 years of pharma/biotech experience with 8+ years in GCP QA, extensive knowledge of ICH guidelines and global regulations, demonstrated experience in audits, and regulatory interactions. Skills include strong organizational, analytical, and cross-functional collaboration capabilities. High-Value: GCP compliance, clinical trial oversight, regulatory inspections, vendor audits, and risk management within ophthalmology clinical programs. Work setup is remote with up to 20% travel. The position reports to the Director, Clinical Quality Assurance.