Manager, QA Validation Oversight

Regeneron Pharmaceuticals

23h • $110,100 - $179,500 • Onsite

About The Position

Regeneron is seeking a Manager, QA Validation Oversight to lead a team responsible for the integrity of process validation processes. The role supports validation activities, promotes global consistency, addresses recurring documentation themes, and contributes to regulatory inspections and compliance. It is based in Rensselaer, New York, and follows a Monday–Friday schedule from 8:00 a.m. to 4:30 p.m. The level may be determined based on experience.

Requirements

• Bachelor’s degree in Engineering, Chemistry, or Life Sciences, or an equivalent combination of education and experience.
• At least 7 years of relevant work experience for the Manager level.
• At least 8 years of relevant work experience for the Senior Manager level.
• Hands-on validation experience in a GMP-regulated environment.
• Ability to build strong, collaborative relationships across global internal teams.
• Continuous improvement mindset.
• Leadership skills to inspire and guide a multi-tiered team.

Responsibilities

• Ensure validation activities align with production initiatives to support successful transition of processes from development to manufacturing.
• Present and defend validation strategies, documentation, and processes to the FDA and other regulatory agencies.
• Review and approve validation documents, procedures, and protocols, proposing modifications and corrections as needed to meet regulatory requirements and expectations.
• Oversee QA Validation activities, including review and approval of failure investigations, change controls, SOPs, validation protocols and summary reports, and validation master plans.
• Hold one-on-one discussions with team members to provide performance feedback and set development goals, fostering professional growth.

Benefits

• Competitive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager