QA Validation Oversight Lead (GMP)

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); In loco; USD 110.000 - 180.000; Tempo pieno

Descrizione del lavoro

Regeneron is seeking a Manager, QA Validation Oversight to lead a team responsible for ensuring the integrity of our process validation activities in a GMP environment. You will align validation with production, present strategies to FDA and other regulators, and oversee validation documents, protocols, and master plans.

This on-site role in Rensselaer, NY requires a bachelor’s degree in Engineering, Chemistry, or Life Sciences and 7+ years of GMP validation experience, with strong leadership

Competenze

• Bachelor’s degree in Engineering, Chemistry, or Life Sciences or equivalent experience.
• Hands-on validation experience in a GMP-regulated environment.
• Strong leadership and collaboration across global teams.
• Continuous improvement mindset and regulatory readiness.

Mansioni

• Align validation activities with production to support smooth tech transfers.
• Defend validation strategies, documents, and processes to FDA and other regulators.
• Review and approve validation documents, protocols, and master plans.
• Oversee all QA Validation activities including investigations, change controls, SOPs, and reports.
• Provide coaching and development feedback to team members.

Conoscenze

Leadership

Team leadership

GMP experience

Collaboration

Continuous improvement

Formazione

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

Descrizione del lavoro

Regeneron is seeking a Manager, QA Validation Oversight to lead a team responsible for ensuring the integrity of our process validation activities in a GMP environment. You will align validation with production, present strategies to FDA and other regulators, and oversee validation documents, protocols, and master plans.

This on-site role in Rensselaer, NY requires a bachelor’s degree in Engineering, Chemistry, or Life Sciences and 7+ years of GMP validation experience, with strong leadership