Provide quality assurance and compliance expertise for Veterinary Medicine Research & Development (VMRD), including the design, execution, and transfer of new biological/biopharmaceutical products to ensure department and site objectives are achieved. Position Responsibilities Ensure VMRD production facilities and the transfer of newly developed and/or improved biological/biopharmaceutical products and processes comply with applicable USDA, EU, FDA, and Zoetis quality standards, as well as the regulatory requirements of destination countries. Work in conjunction with VMRD Development Science & Technology (DST) colleagues on scale-up, technical transfers and coordination of regulatory issues. Serve as QA consultant for development, clinical, and VICH batches/serials. Support VMRD colleagues and initiatives by providing regulatory documents and manufacturing quality/compliance resources. Review new product master batch records, manufacturing documents, and analytical documents for accuracy, completeness, and compliance with Outlines of Production/submissions, and provide QA approval. Review and approve validation protocols and reports. Work closely with VMRD, VMRA and GMS in the preparation and review of Outlines of Production/submissions. Conduct and review deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other GMP functions. Provide guidance and oversight in identifying root cause, corrective actions/preventative actions (CAPAs), and effectiveness checks of CAPAs. Evaluate and approve changes to manufacturing and packaging equipment and processes, testing, IT systems, and other GMP documents and programs. Ensure the processes, systems, and facilities of outside suppliers of raw materials and components procured by Lincoln Operations are maintained to provide quality products. Author risk assessments as necessary within project teams. Ensure continued regulatory compliance within Lincoln Operations by actively participating on teams 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. Maintain a high level of contemporary knowledge in the technical and regulatory disciplines appropriate to vaccine/biopharmaceutical development. Has deep/ significant knowledge of varied aspects of pharmaceutical/biopharmaceutical/vaccine quality. Applies technical skills and functional knowledge independently and proactively. May act as a technical resource within own group/team. Decisions impact own work/ work group and may impact at the team level. Decisions have moderate effect on the delivery of scheduled projects. Makes decisions that resolve moderately complex problems. Works in loosely defined situations within team, where there is significant uncertainty of outcome. Exercise judgment utilizing established approaches as well as prior work experience, consulting others appropriately. Works under limited supervision. Receives instructions primarily on unusual or complex problems. Use or develop novel processes or hypotheses; new ideas and knowledge are used frequently. Recognizes unmet needs and proposes solutions. Modifies existing process to improve the efficiency of the work group or function. Frequently contributes to achievement of goals at the work group, team or function level as a full team participant. Takes responsibility for a portion of the team's milestones or deliverables. Proactively offers to investigate a problem using own resources to resolve an issue. May provide training/ coaching/ mentoring within work group/ team. May supervise other colleagues. Influences at the work group and/or project team level Education and Experience Bachelor's degree with 10 years of relevant experience, or a master's degree with 8 years of relevant experience, or equivalent combination of education and experience in biological or pharmaceutical sciences, engineering, or a related discipline. Minimum of 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs within the veterinary or human pharmaceutical or biological products industry. Technical Skills and Competencies Experience with Quality Assurance auditing, current Good Manufacturing Practices (cGMP), and quality systems. Technical understanding of aseptic practices. Thorough knowledge of U.S. and EU regulations governing biological products and their practical application. Strong technical and analytical skills, with the ability to evaluate information, draw sound conclusions, and make informed decisions. Knowledge of Right First Time (RFT) and Lean principles. Strong written and verbal communication skills, with the ability to effectively communicate and collaborate with internal and external stakeholders at all levels. Demonstrated interpersonal skills and the ability to build effective working relationships. Excellent organizational skills and strong attention to detail and accuracy. Ability to adapt to changing conditions and priorities while maintaining flexibility and effectiveness. Preferred Qualifications: Master's or PhD degree in a biological science or chemical/bioprocess engineering. Expert-level competency in the validation of processes, equipment, cleaning procedures, software, and computerized systems. Solid knowledge of Zoetis biological and biopharmaceutical products. Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications. 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. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [email protected] to request an accommodation. 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. At Zoetis, our purpose is to nurture our 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.

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