QA Validation Oversight Manager – GMP & Regulatory

Regeneron Pharmaceuticals, Inc.; City of Troy (NY); On-site; USD 110,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals in Rensselaer, NY is seeking a Manager, QA Validation Oversight to lead a team ensuring the integrity of our process validation activities across development and manufacturing.

You will present validation strategies to FDA and regulators, review validation documents, and oversee audits, change controls, SOPs, and master plans while developing team members and fostering a culture of continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Chemistry, or Life Sciences.
• 7+ years of relevant experience for Manager; 8+ years for Senior Manager.
• Hands-on validation experience in a GMP-regulated environment.
• Leadership skills to inspire and guide a multi-tiered team.

Responsibilities

• Align validation activities with production initiatives to support transfer from development to manufacturing.
• Present/defend validation strategies, documentation, and processes to FDA and regulators.
• Review and approve validation documents, procedures, protocols, and reports; propose modifications to meet regulatory requirements.
• Oversee all aspects of QA Validation including reviews of failure investigations, change controls, SOPs, validation protocols and master plans.
• Conduct one-on-one discussions with team members to review performance and set development goals.

Skills

Leadership

Cross-functional collaboration

GMP experience

People management

Education

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

Job description

Regeneron Pharmaceuticals in Rensselaer, NY is seeking a Manager, QA Validation Oversight to lead a team ensuring the integrity of our process validation activities across development and manufacturing.

You will present validation strategies to FDA and regulators, review validation documents, and oversee audits, change controls, SOPs, and master plans while developing team members and fostering a culture of continuous improvement.