Associate Director, Global Patient Safety Standards & Training

Role: Associate Director in Global Patient Safety (GPS) Standards & Training, responsible for establishing and maintaining PV procedures aligned with regulatory requirements and industry standards. Objectives include ensuring audit readiness, procedural compliance, and continuous improvement of PV processes. Responsibilities encompass managing procedural updates, acting as SME for PV process design, coordinating with Process & Procedures teams, overseeing CAPAs, and supporting audit/inspection activities. The role involves close cross-functional collaboration with SMEs, process owners, and quality teams, and requires serving as a liaison to Learning & Development functions. Location is on-site in Sleepy Hollow, NY; Warren, NJ; or Cambridge, MA, with approximately 25% travel. Requirements: Bachelor’s degree, 7+ years in PV, Regulatory Affairs, or Quality Assurance within pharma/biotech, with deep knowledge of PV regulations and quality management systems. Proven experience in PV process design, procedural management, and project coordination. Preferred: experience with Data Privacy and successful audit/inspection presentations. High-value specifics include focus on PV compliance, procedural integrity, and process optimization within a fast-growing biopharma setting.