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Regeneron
Manager, QA Validation OversightRegeneron • Rensselaer, NY, United States
Manager, QA Validation Oversight

Manager, QA Validation Oversight

Regeneron • Rensselaer, NY, United States
3 days ago
Job type
  • Full-time
Job description

Manager, QA Validation Oversight

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.

Location: Rensselaer, NY

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

Discover your role:

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

This role requires:

  • Bachelor's degree in Engineering, Chemistry, or Life Sciences degree, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
    • Associate Manager: 6+ years
    • Manager: 7+ years
    • Level will be determined based on experience
  • Hands-on validation experience in a GMP-regulated environment
  • Deep understanding and expertise in Process Validation
  • Enjoying building strong, collaborative relationships across global internal teams
  • A continuous improvement mindset
  • Leadership skills that inspires and guides a multi-tiered team
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Manager, QA Validation Oversight • Rensselaer, NY, United States

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