QA Validation Oversight Manager — Global Compliance Leader

BioSpace; City of Troy (NY); On-site; USD 110,000 - 180,000; Full time

Job summary

Regeneron is seeking a Manager, QA Validation Oversight in Rensselaer, NY, to lead a team ensuring the integrity of process validation. You will align validation with production, defend strategies to regulatory bodies, and drive continuous improvement across global teams.

Responsibilities include reviewing validation docs, protocols, and summaries; overseeing change controls, SOPs, and master plans; and coaching the team to achieve development goals in a fast-paced GMP environment.

Qualifications

• Hands-on validation experience in a GMP-regulated environment.
• Leadership skills that inspire and guide a multi-tiered team.
• Ability to build collaborative relationships across global internal teams.
• Continuous improvement mindset for process validation activities.

Responsibilities

• Lead and oversee QA Validation activities to ensure process integrity.
• Present/defend validation strategies and documentation to FDA and other agencies.
• Review and approve validation documents, protocols, and summary reports.
• Oversee change controls, CAPAs, SOPs, and validation master plans.
• Conduct one-on-one discussions to review performance and development goals.

Skills

GMP-regulated validation experience

Leadership skills

Continuous improvement mindset

Cross-functional collaboration

Education

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

Job description

Regeneron is seeking a Manager, QA Validation Oversight in Rensselaer, NY, to lead a team ensuring the integrity of process validation. You will align validation with production, defend strategies to regulatory bodies, and drive continuous improvement across global teams.

Responsibilities include reviewing validation docs, protocols, and summaries; overseeing change controls, SOPs, and master plans; and coaching the team to achieve development goals in a fast-paced GMP environment.