QA Validation Oversight Manager | Regulatory Compliance

Regeneron Pharmaceuticals, Inc.; 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

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.