The Sr. Manager/Assoc. Director, Validation, leads the Validation group in MSAT and is accountable for Cellectis Raleigh’s overall validation program for equipment, facilities and utilities, control and/or data recording systems, and Process Performance Qualification (“process validation”). Ensures that validation approaches are consistent with industry standards (cGMPs, GAMP 5, ISPE guidelines, ICH guidelines). Strong working knowledge and practical approach to FDA/EU regulatory requirements and guidance documents, including Data Integrity. Interfaces closely with Quality Assurance and with equipment/system/area owners in Facilities/Metrology, Manufacturing Operations, Quality Control laboratories, Supply Chain/Warehouse, and IT/CSV to ensure that initial qualifications and periodic requalifications are robust and meet industry standards. Also works globally with Quality, Regulatory Affairs, Process and Analytical Development, MS&T, and Manufacturing Operations to design and execute the Process Performance Qualification campaigns for pivotal programs.