Associate Director, GxP Operations Support Manufacturing Systems

Role: Associate Director, GxP Operations Support Manufacturing Systems, leading strategic development and continuous improvement of manufacturing execution systems (MES) supporting clinical and commercial biopharma manufacturing. Responsibilities: partner across manufacturing, quality, IT, and engineering to implement digitalization initiatives; design scalable automation solutions; oversee lifecycle management, cybersecurity, data integrity, and compliance with GMP, GAMP, and 21 CFR Part 11 standards; establish KPIs, foster innovation, and provide technical leadership. Requirements: bachelor’s in Engineering, Information Systems, Biotechnology, or related field; minimum 8 years’ experience in GMP pharmaceutical/biopharma manufacturing systems, MES platforms (notably POMSnet), automation, and data infrastructure; strong knowledge of GMP regulations, validation, and data integrity. High-Value: focus on biopharma manufacturing environment, with emphasis on digital manufacturing, automation engineering, and GMP compliance. WorkSetup: on-site, five days per week, with ad hoc flexibility; some travel may be required.