Manager, QA Validation Oversight at Regeneron Pharmaceuticals | NY, US | Rezi

Manager, QA Validation Oversight at Regeneron Pharmaceuticals

Manager, QA Validation Oversight

Regeneron Pharmaceuticals · NY, US

Yesterday

Manager, QA Validation Oversight

Regeneron Pharmaceuticals · NY, US

2 days ago
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About the Role

Regeneron is seeking a Manager, QA Validation Oversight to lead a team ensuring the integrity of process validation. This role supports validation activities, ensures global consistency, addresses documentation themes, and plays a key role in regulatory inspections and compliance.

Responsibilities

  • Ensuring alignment between validation activities and production initiatives to support successful 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 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.

Requirements

  • Hands-on validation experience in a GMP-regulated environment
  • Enjoying building strong, collaborative relationships across global internal teams
  • A continuous improvement mindset
  • Leadership skills that inspires and guides a multi-tiered team
  • As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Location

  • Rensselaer, New York, United States

Work Type

  • Onsite

Experience Level

  • Manager: 7+ years
  • Senior Manager: 8+ years

Education Level

  • Bachelor’s degree in Engineering, Chemistry, or Life Sciences degree, or equivalent combination of education and experience

Salary/Compensations

  • $110,100.00 - $179,500.00

Benefits

  • 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

About the Company

  • At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
  • We are committed to building a workplace with an inclusive culture.
  • At Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

Equal Opportunity

  • Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
  • Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.