Manager - Product Development Quality

Zoetis Inc; Oklahoma; On-site; USD 120,000 - 180,000; Full time

Job summary

Zoetis Inc. is seeking a senior QA/Compliance professional for Veterinary Medicine Research & Development (VMRD) in the United States.

The role focuses on ensuring quality, regulatory compliance, and successful technology transfers of biopharmaceutical products. You will work with Development Science & Technology and cross-functional teams to maintain high regulatory standards, review critical documents, and drive CAPA processes while mentoring colleagues.

Qualifications

• Bachelor's degree with 15 years' experience, or equivalent, in biological/pharmaceutical sciences or related discipline.
• Minimum of 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs within veterinary or human pharmaceutical/biological products.
• Experience with quality audits, cGMP, and quality systems; regulatory knowledge of US/EU requirements.

Responsibilities

• Provide QA and compliance expertise for VMdR progrms, including design, execution, and transfer of products.
• Ensure facilities and transfers comply with USDA, EU, FDA, and Zoetis quality standards and regulatory requirements.
• Review master batch records, manufacturing and analytical documents for accuracy and compliance; approve validation protocols/reports.
• Assist with regulatory documents, CAPAs, and supplier QA activities; support cross-functional teams on scale-up and technology transfers.
• Provide guidance on deviations, investigations, and CAPAs; mentor and lead in a team setting.

Skills

QA auditing

cGMP compliance

Quality systems

Regulatory knowledge (US/EU)

Right First Time (RFT)

Lean principles

Oral and written communication

Analytical skills

Problem solving

Education

Bachelor's degree in biological/pharmaceutical sciences or related discipline

Master's or PhD in biological science or chemical/bioprocess engineering (preferred)

Job description

Position Responsibilities

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. Evaluates and approves 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. Such assurance will be achieved by coordinating and participating in audits and pre-approval surveys of key and potential suppliers, as necessary. 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 advanced/specialized knowledge of varied aspects of pharmaceutical/biopharmaceutical/vaccine quality. Applies technical and functional knowledge to design/ develop work, and independently completes work within own team, working on multiple assignments in parallel. Acts as a technical resource within own team/ function. Decisions consistently impact work group/ team/ function. Decisions affect project delivery and may impact expenditure on existing/ alternative resources. Makes decisions that require developing new options to resolve moderately complex problems. Works in ambiguous situations within team/ function, where there is moderate uncertainty of outcome. Exercises judgment utilizing breadth of knowledge and prior work experience. May become a resource for others. Works independently; solicits directional review from others. May independently develop approach to solutions. Proactively gathers input from others to assist with novel aspects of the job. Frequently develops and may create novel processes and hypotheses using new ideas and knowledge. Implements new techniques or approaches that are moderately complex, to meet unmet technical or process needs. Adapts existing technology to new applications. Regularly contributes as a full team participant. Regularly takes informal leadership role to facilitate agreements and move the team toward its goals. Proactively offers support and resources to achieve a team goal. May contribute to strategic direction of function or line on teams. Directly influences team decision making and achieving agreement. Provide formal/ informal mentoring/ coaching within own workgroup / team. May supervise other colleagues. Influences at the functional and/or project team level. Identifies and develops activities/ projects to support short-term operational goals.

Education and Experience

Education and Experience Bachelor's degree with 15 years' experience, or equivalent, in biological or pharmaceutical sciences, engineering, or 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

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

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

Full time Regular Colleague

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 [e-mail] 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.

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.