GRC Analyst
TTM Technologies
Cyber Security
Regulatory Compliance Leader
Zoetis
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob 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.
