External Site Lead, Global External Manufacturing

Role: External Site Lead within the Global External Manufacturing Team, responsible for overseeing manufacturing partnerships with CDMOs for biologics or pharmaceutical products. Objectives include ensuring seamless manufacturing operations, process control, compliance, and continuous improvement. Responsibilities encompass managing CDMO relationships, providing technical oversight for assembly, labeling, packaging, executing change controls, managing technology transfers, analyzing datasets for process robustness, authoring CPV reports, and driving operational efficiencies. Qualifications: Bachelor's degree in Engineering or related field, with at least 7 years of experience in device assembly, packaging, or operations, along with expertise in cGMP, FDA/EMA regulations, and external CDMO management. Preferred skills include strong project management, cross-functional leadership, analytical capabilities, and regulatory knowledge. High-Value Details: Focus on biologics/pharmaceutical manufacturing, process control strategies, regulatory compliance, and global change management. The role involves cross-functional collaboration across manufacturing, quality, and supply chain teams, with a management level responsible for strategic oversight. Location: Not specified, but involves managing global external manufacturing sites.