Manager, QA (Process Validation Oversight)

Manager, QA (Process Validation Oversight)

Regenereon is hiring a Manager, QA (Process Validation Oversight) to 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 validation master plans.
• Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.

This role might be a fit for you if you :

To be considered for this role, you must hold a Bachelor's degree in Engineering, Chemistry, or Life Sciences degree and the following minimum years of experience for each level :

May substitute relevant experience in lieu of education requirement. Level is determined on qualifications relevant to the role.