Director, Data Management Process, Quality & Inspection Readiness

Role: Strategic leader overseeing Data Management quality and inspection readiness within a biotech/pharma setting, ensuring compliance with GCP, ICH, and global regulatory standards. Responsibilities: develop and implement quality frameworks, lead inspection preparedness, manage audits, oversee CAPA activities, and drive continuous process improvements; establish KPIs/KQIs for performance monitoring; support regulatory inspections across multiple authorities; and develop training programs. Lead and mentor the Data Management team, fostering a culture of quality and accountability. Requirements: Bachelor's degree in Science, Health, Computing, or related field; 12+ years in clinical Data Management in biopharma, with 5+ years of leadership experience. Deep expertise in GCP, ICH, 21 CFR Part 11, and inspection readiness, with proven track record supporting health authority inspections (FDA, EMA, etc.). Strong process development, quality management, and cross-functional collaboration skills. High-Value: focus on global clinical Data Management, quality frameworks, inspection readiness, CAPA, and compliance in a regulated environment. Work setup: on-site (Warren, NJ; Tarrytown, NY; Armonk, NY), 4 days/week, with 25% travel.