Manager, QA Validation Oversight

BioSpace; City of Troy (NY); On-site; USD 110,000 - 180,000; Full time

Job summary

Regeneron is seeking a Manager, QA Validation Oversight in Rensselaer, NY, to lead a team ensuring the integrity of process validation. You will align validation with production, defend strategies to regulatory bodies, and drive continuous improvement across global teams.

Responsibilities include reviewing validation docs, protocols, and summaries; overseeing change controls, SOPs, and master plans; and coaching the team to achieve development goals in a fast-paced GMP environment.

Qualifications

• Hands-on validation experience in a GMP-regulated environment.
• Leadership skills that inspire and guide a multi-tiered team.
• Ability to build collaborative relationships across global internal teams.
• Continuous improvement mindset for process validation activities.

Responsibilities

• Lead and oversee QA Validation activities to ensure process integrity.
• Present/defend validation strategies and documentation to FDA and other agencies.
• Review and approve validation documents, protocols, and summary reports.
• Oversee change controls, CAPAs, SOPs, and validation master plans.
• Conduct one-on-one discussions to review performance and development goals.

Skills

GMP-regulated validation experience

Leadership skills

Continuous improvement mindset

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.

When & Where

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

• Bachelors 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. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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