Manager, QA Validation Oversight

Location: Rensselaer, NY
Work model: Monday-Friday, 8am-4:30pm

About the Role

Ensure alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing. Collaborate closely with the internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies. Present and defend validation strategies, documentation, and processes to FDA and other regulatory agencies. Review and approve process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations. Oversee 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-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.

Responsibilities

• Ensure alignment between validation activities and Process Sciences initiatives to support the transition of processes from development to manufacturing.
• Collaborate with the internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.
• Present and defend validation strategies, documentation, and processes to FDA and other regulatory agencies.
• Review and approve process validation documents, procedures, and protocols; propose modifications and corrections to meet regulatory requirements.
• Oversee all aspects of QA Validation, including review and approval of failure investigations, change controls, SOPs, validation protocols, summary reports, and validation master plans.
• Conduct one-on-one discussions with team members to review performance feedback and set development goals.

Requirements

• Bachelor’s degree in Engineering, Chemistry, or Life Sciences, or equivalent combination of education and experience.
• Relevant work experience:
  • Associate Manager: 6+ years
  • Manager: 7+ years
• Hands-on validation experience in a GMP-regulated environment.
• Deep understanding and expertise in Process Validation.
• Ability to build strong, collaborative relationships across global internal teams.
• Continuous improvement mindset.
• Leadership skills that inspire and guide a multi-tiered team.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits, 401(k) company match.
• Health and wellness programs, fitness centers.
• Insurance benefits (e.g., medical, dental, vision, life, and disability).
• Paid time off.
• Family support benefits.

Pay

Salary Range (annually): $90,800.00 - $173,400.00