Regulatory Compliance Leader - Zoetis : Job Details

Join to apply for the Regulatory Compliance Leader role at Zoetis3 weeks ago Be among the first 25 applicantsJoin to apply for the Regulatory Compliance Leader role at ZoetisGet AI-powered advice on this job and more exclusive features.Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.Benefits Include:4 weeks accrued paid vacation and 13 paid holidays.401(k) match with company profit sharing.Tuition reimbursement and Student Loan repayment program.Great Health, personal, and family benefits starting day 1.Position SummaryThe 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.Hours: 1st Shift.Position ResponsibilitiesPlan, 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 OperationsBe 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 AdministrationReview/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 ResponsibilitiesLeadership Development / Coaching of Staff; Creation of Learning Organization for the Regulatory ComplianceParticipate 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 ExperienceBiological/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 RequiredDoes well in a Change Management Environment, Acts as a Change AgentProblem solver, root cause analysis methodologyProcess oriented mindset; data and continuous improvement orientationAble to work well in complex environment.Physical Position RequirementsPosition located in Lincoln, NEMinimal off-site travelThis position requires sitting, standing, and walking with occasional overtime/weekend work.About ZoetisAt Zoetis , our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.Global Job Applicant Privacy NoticeSeniority level Seniority level Entry levelEmployment type Employment type Full-timeJob function Job function Manufacturing, Project Management, and Quality AssuranceIndustries Pharmaceutical ManufacturingReferrals increase your chances of interviewing at Zoetis by 2xSign in to set job alerts for “Regulatory Specialist” roles. 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