Manager

• Ownership for the development and execution of the Project Validation Master Plan (PVMP)
• Support the writing and approval of URSs (User Requirement Specifications) for facilities, equipment and systems.
• Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, as well as facilities and utilities
• Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities
• In partnership with E&PS own Computer Systems Validation, including writing and driving CSV protocols, Functional Specification (FS), Design Specification (DS) plus Functional Acceptance Test (FAT) and Site Acceptance Test (SAT), Integration testing (IQ), and Functional testing (OQ)
• Accountable for cost and resources within system(s) of responsibility
• Support resolving of technical issues or roadblocks as fast as possible including lessons learned
• Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
• Leading role in compliance inspections / audits within area of responsibility
• Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
• Provide leadership and act as expert in the field C&Q
• Maintain partnerships with contractors and vendors that execute C&Q, Re-qualification, and PQ activities
• Establish and manage critical metrics and tracking tools across C&Q scope
• Site requalification activities at the Quality Site Management Review (QSMR) level
• Actively communicate regularly with the Engineering community and foster expertise sharing with CAR-T entities around the globe
• Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings.

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