Manager, QA Validation Oversight

Job description

Regeneron is hiring a Manager, QA Validation Oversight t o lead a team dedicated to ensuring the integrity of our process validation processes . This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance. In this role, a typical day might include the following: Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing. Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies. Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies. Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations. Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validati...