Sr. Manager QA Drug Product (Filling)

Regeneron PharmaceuticalsRensselaer, NY
Onsite

About The Position

Regeneron is currently seeking a Sr Manager Quality Assurance to join our internal QA Drug Product Manufacturing team. This role is responsible for quality floor oversight of the filling (i.e. equipment prep, formulation, and filling) operations for SA12. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Requirements

  • Proven leadership in cGMP environments, including experience speaking and preparing for regulatory inspections and audits.
  • Strong collaboration and communication cross-functionally
  • Ability to think critically, and continuously improve processes
  • Ability to lead a department through a fast-paced and dynamic environment
  • Must have a BS/BA in Life Sciences or related field and 8+ years of experience.
  • Previous supervisory/ people leadership experience is required.
  • May substitute proven experience for education requirement.

Nice To Haves

  • Experience in fill/finish manufacturing is preferred.

Responsibilities

  • Provide leadership to multiple teams under your supervision, including being responsible for Quality oversight of all equipment prep, formulation, and filling (multiple lines)
  • Responsible for programs that support the department, for example: area walkthroughs
  • Support development and growth of team, including your people leaders
  • Leadership point of contact for escalation of events, process updates, etc.

Benefits

  • health and wellness programs (including medical, dental, vision, life, and disability insurance)
  • fitness centers
  • 401(k) company match
  • family support benefits
  • equity awards
  • annual bonuses
  • paid time off
  • paid leaves (e.g., military and parental leave)
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