Zoetis

Regulatory Compliance Leader

Zoetis

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

About the role

  • Lead the Regulatory Compliance organization (~25 colleagues) and report to Site Quality Leader.
  • Ensure products released are in strict compliance to dossiers on file with agencies throughout the world.
  • Primary liaison for USDA-CVB Establishment License #190 and interact with CVB-IC.
  • Plan, initiate and manage policies, processes, and procedures for Regulatory Compliance.
  • Lead Correspondence with US Agencies (CVB-IC and FD-ORA).
  • Manage and guide the Regulatory Compliance team leaders.
  • Accountable for Product Release (SFG and FG), investigation of customer complaints, Annual product reviews, Lincoln Operations stability program.
  • Ensure current facility documents are on file for relevant agencies (e.g., CVB Blue Prints and Legends, Site Master File).
  • Maintain registrations with the US Drug Enforcement Administration.
  • Review/approve Artwork change control.
  • Manage Recalls/Market Actions for Lincoln Operations products.
  • Participate and lead in yearly and long-range budget planning of personnel and operating expenses.
  • Develop and maintain performance and predictive metrics to guide Regulatory Compliance.
  • Leadership Development / Coaching of Staff; Ensure Training and Development plans are in place.
  • Participate in the Quality Culture across the Site.
  • Minimal off-site travel; position located in Lincoln, NE; 1st Shift.

Requirements

  • Biological/Chemistry based degree: B.S. with 14 years, M.S. with 12 years, or DVM/Ph.D. with 9 years, with direct experience in biological or pharmaceutical science development or manufacture.
  • A minimum of five years management experience including budget and supervisory responsibilities.
  • A minimum of five years progressive experience in the quality assurance, manufacturing, quality control, or regulatory affairs function of veterinary or human pharmaceuticals or biological.
  • A thorough familiarity with requirements of USP, EP and 9 CFR for biological and pharmaceutical products, including the Regulations (FDA, USDA & EMA) for biological and pharmaceutical products.
  • Does well in a Change Management Environment, Acts as a Change Agent
  • Problem solver, root cause analysis methodology
  • Process oriented mindset; data and continuous improvement orientation
  • Able to work well in complex environment.
  • All applicants must possess or obtain authorization to work in the US for Zoetis.