Manager Quality Assurance
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend on.Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.Position SummaryDirect the Quality Assurance functions for the Lincoln Nebraska site to ensure that only Lincoln Biological and Pharmaceutical products meeting high quality standards, customer expectations, and regulatory requirements are provided to our customers Position Responsibilities* Direct and oversee the Biological and Pharmaceutical Quality Assurance Managers. Plan, initiate, and direct policies, processes and procedures to ensure all biological and pharmaceutical products manufactured by Lincoln Operations meet applicable USDA, EU, FDA, and Zoetis quality standards, as well as the regulatory requirements of all destination countries.* Direct quality assurance staff providing Quality oversight of the VMRD Master Seed and Pilot Facility. Contribute to consistency of procedures, processes and Quality Assurance activities between manufacturing and VMRD GMP facilities. Ensure new and existing product transfers are completed in accordance with GMPs and Zoetis quality standards.* Direct the Quality Assurance Teams to ensure the processes, systems, and facilities utilized at Lincoln Operations manufacturing sites are continuously operating in compliance with government regulations and Zoetis guidelines by coordinating and participating in periodic audits or inspections of the site.* Ensure all product quality and/or regulatory actions such as quarantine hold, stop sales, withdrawal actions, or recalls of biological and pharmaceutical products manufactured by or distributed by Lincoln Operations are performed according to regulatory requirements and Zoetis Quality Standards.* Manage Quality Assurance in an effective manner within budget guidelines, where possible.* Ensure consistent manufacturing and control systems are in place by overseeing the review and approval of all critical Standard Operating Procedures and all manufacturing Batch Records.* Monitor and identify when improvements are needed with the Quality Assurance activities of Lincoln Biological and Pharmaceutical Operations.* Ensure a proficient and knowledgeable GMP auditing and inspection staff, by providing periodic training on pertinent subjects and, where applicable, provide the opportunity to achieve formal certification recognized by international authorities.* Ensure continued regulatory compliance within Lincoln Biological and Pharmaceutical Operations by actively participating on key teams and task forces and making appropriate recommendations when needed to assure compliance. * Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.* Actively monitor individual market (e.g., Turkey, Russia) interpretation of the GMPs. * Act as primary escort for GMP regulatory inspections and actively participate in all other regulatory inspections of the Zoetis-Lincoln facility, where required.* Actively manage identified inspection deficiencies (i.e., Board of Health Findings) including follow up with partner groups to deficiency closing and reporting to inspecting agencys.* Actively and directly participate in industry and trade association committees to align Zoetis Quality Standards, government regulations, and the quality needs of Animal Health customers. Education and Experience* Ph.D. With nine years, M S. With twelve years, B. S. With fourteen years or equivalent in biological or pharmaceutical sciences, or related discipline.* A minimum of five years QA/QC management experience including budget and supervisory responsibilities.* A thorough familiarity with US and EU Regulations (FDA, USDA & VMD) for pharmaceutical and biological products and their application.* Excellent written and verbal communication skills Technical Skills and CompetenciesMinimum Qualifications:* Demonstrated ability to perform and reach targeted conclusions.* Strong written and oral communication and ability to effectively direct a team of professionals.* Ability to establish appropriate timelines to meet project milestones and hold colleagues accountable to timelines and activities.* Process and detail oriented with the ability to review and/or prepare detailed structured documents.* Ability to develop solutions to routine and complex problems.* Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work.* Ability to communicate effectively with Team Members to facilitate completion of required Quality Assurance activities to meet all deadlines.* Strong technical background in Biological, Bio-pharmaceutical, and Pharmaceutical productsPreferred Qualifications:* Demonstrated knowledge of the Deviation and Change Control processes.* Demonstrated knowledge in Laboratory Information Management (LIMS) and Manufacturing systems (SAP).* Direct experience in hosting regulatory inspections and subsequent closure of inspection deficiencies* Experience in validation of processes, analytical methods, equipment, cleaning, software, computer systems, etc.* Demonstrated ability leading a complex team and influencing colleagues with no direct report relationship.* Hands on experience with change manApply for this job.