Regulatory Compliance Leader

Recruiter- Global Manufacturing and Supply- Zoetis Position Summary The position reports to the Site Quality Leader of Lincoln Operations and is a member of the Quality Operations Leadership team and will lead the Regulatory Compliance organization consisting of ~25 professional colleagues. The Regulatory Compliance organization is responsible for ensuring that products released are in strict compliance to dossiers on file with agencies throughout the world. The leader will be accountable for maintaining current dossiers and relevant facility documents and will monitor Lincoln Operations compliance activities. This individual will be the primary liaison for USDA-CVB Establishment License #190 and is expected to routinely interact with CVB-IC. The Site Regulatory Compliance Leader is a key stakeholder in fostering the Quality Culture, setting strategic direction of Quality Operations as well as managing day-to-day activities of Regulatory Compliance. The leader will use data and metrics to meet site compliance imperatives to maintain product supply and drive continuous improvement. Position Responsibilities Plan, initiate and manage the policies, processes, and procedures for the Regulatory Compliance organization to ensure compliance of biological and pharmaceutical products released by Lincoln Operations (including White Hall, and Charles City) with global product dossiers, Zoetis Quality Standards, and customer expectations. Lead Correspondence with US Agencies (CVB-IC and FD-ORA) Manage and guide the Regulatory Compliance team leaders. Be accountable for Product Release (SFG and FG) Be accountable for investigation of customer complaints with respective to product quality. Be accountable for Annual product reviews for Lincoln Operations Be accountable for the Lincoln Operations stability program. Ensure current facility documents are on file or available for relevant agencies (e.g., CVB Blue Prints and Legends, Site Master File) Maintain current registrations with the US Drug Enforcement Administration Review/approve Artwork change control. Be accountable for updates/changes to dossiers (USDA and International) Manage needed 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 both performance and predictive metrics to guide Regulatory Compliance and identify capacity restraints and issues. Staff and Leadership Responsibilities Leadership Development / Coaching of Staff; Creation of Learning Organization for the Regulatory Compliance Participate in the Quality Culture across the Site. Ensure Training and Development plans are in place for all Regulatory Compliance colleagues. Development of Regulatory Compliance budget and resource planning for roll up to the Site Quality Budget. Support the development of Quality Operations goals and targets as part of the organization’s strategic plan. Education and Experience 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. Technical Skills and Competencies Required 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. Physical Position Requirements Position located in Lincoln, NE Minimal off-site travel Job Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance, Project Management, and Product Management Industries: Pharmaceutical Manufacturing and Biotechnology Research Lincoln, NE $120,000.00-$150,000.00 #J-18808-Ljbffr