Manager, QA Validation Oversight

Regeneron; New York (NY); On-site; USD 110,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Manager, QA Validation Oversight to lead a team ensuring integrity of process validation activities from development to manufacturing. You will align validation with production initiatives and defend strategies before FDA and other regulatory bodies.

The role oversees validation documents, protocols, investigations, change controls, SOPs and validation master plans, and mentors a multi-tiered team to drive continuous improvement across sites.

Qualifications

• Bachelor's degree in Engineering, Chemistry, or Life Sciences is required.
• 7+ years of relevant work experience for Manager level.
• Hands-on validation experience in a GMP-regulated environment.
• Ability to build strong, collaborative relationships across global teams.

Responsibilities

• Align validation activities with production to support transfer from development to manufacturing.
• Present/defend validation strategies, documents, and processes to FDA and other regulators.
• Review and approve validation documents, protocols, SOPs, investigations, changes, and master plans.
• Oversee QA Validation activities including failure investigations and validation reports.
• Lead one-on-one discussions to review performance and development goals.

Skills

GMP validation

Regulatory inspections

Leadership

Cross-functional collaboration

Documentation review

Education

Bachelor's degree in Engineering, Chemistry, or Life Sciences

Job description

Team: Industrial Operations & Product Supply

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking 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 validation activities, ensuring global consistency, addressing recurring themes in documentation, and playing a pivotal role in regulatory inspections and compliance.

When & where

Discover your role

• Ensuring alignment between validation activities and production initiatives to support successful transition of processes from development to manufacturing.
• Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
• Reviewing and approving 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 requires

• Bachelor's degree in Engineering, Chemistry, or Life Sciences degree, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
  • Manager: 7+ years
  • Senior Manager: 8+ years
  • Level will be determined based on experience
• Hands-on validation experience in a GMP-regulated environment
• Enjoying building strong, collaborative relationships across global internal teams
• Leadership skills that inspires and guides a multi-tiered team

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$110,100.00 - $179,500.00

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What people ask before they join

We take hiring seriously - because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire.

Part of the team

Where You'll Make an Impact

Here, you'll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

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Our hiring process

From application to your first day - here's how it works.

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See something you like? Submit your application for the role that fits your background and goals.

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4. DECISION

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5. WELCOME

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