QA Validation Oversight Lead (GMP)

Regeneron Pharmaceuticals, Inc.; 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

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.