Manager, QA Validation Oversight

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 110,000 - 180,000; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health benefits

Job summary

Regeneron is seeking a Manager, QA Validation Oversight to lead a team ensuring the integrity of process validation activities. The role supports global consistency, quality documentation, and regulatory inspections, with on-site responsibilities in Rensselaer, NY.

Qualifications include a Bachelor’s in Engineering, Chemistry, or Life Sciences and 7+ years of relevant GMP validation experience for managers, with senior levels requiring more.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, or Life Sciences or equivalent experience.
• Hands-on validation experience in a GMP-regulated environment.
• Leadership skills that inspire and guide a multi-tiered team.

Responsibilities

• Ensuring alignment between validation activities and production initiatives to support 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 to meet regulatory requirements.
• 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-to-one discussions with team members to review performance feedback and set development goals.

Skills

GMP validation

Leadership

Cross-functional collaboration

Education

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

Job description

Build our future together: 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.

Location: Rensselaer, New York, United States Work model: Monday-Friday, 8am-4:30pm

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
• A continuous improvement mindset
• Leadership skills that inspires and guides a multi-tiered team

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.

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
• 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.

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.

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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.