Manager, QA Validation Oversight

Regeneron is hiring a Manager, QA 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 for you if you: 

• Bring hands-on validation experience in a GMP-regulated environment. 

• Possess deep understanding and expertise in Process Validation. 

• Enjoy building strong, collaborative relationships across global internal teams. 

• Have a continuous improvement mindset. 

• Are an experienced leader who inspires and guides a multi-tiered team. 

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: 

• Associate Manager: 6+ years 

• Manager: 7+ years 

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

#REGNQA 

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations f