Manager - Product Development Quality

Zoetis•Lincoln, NE

About The Position

Provide quality assurance and compliance expertise for Veterinary Medicine Research & Development (VMRD), including the design, execution, and transfer of new biological and biopharmaceutical products, to help achieve department and site objectives. Ensure VMRD production facilities and product and process transfers comply with applicable USDA, EU, FDA, Zoetis, and destination-country requirements. Work with Development Science & Technology colleagues on scale-up, technical transfers, and regulatory coordination, and serve as a QA consultant for development, clinical, and VICH batches or serials. The role reviews and approves product and manufacturing documentation, validation materials, and changes to GMP processes and systems. It supports regulatory submissions and manufacturing compliance, investigates deviations, and guides root-cause analysis and CAPAs. The position also supports supplier quality through audits and pre-approval surveys, advises management on regulatory deficiencies, and maintains contemporary technical and regulatory knowledge relevant to vaccine and biopharmaceutical development. This position applies advanced or specialized pharmaceutical, biopharmaceutical, and vaccine quality expertise. It independently handles multiple assignments, develops approaches to moderately complex problems, adapts technology to new applications, and contributes technical guidance and informal leadership within teams. It may mentor or coach colleagues and may supervise other colleagues.

Requirements

Bachelor's degree with 15 years of experience, or equivalent, in biological or pharmaceutical sciences, engineering, or a related discipline.
At least 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs in the veterinary or human pharmaceutical or biological products industry.
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, including 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 and the ability to collaborate with internal and external stakeholders at all levels.
Demonstrated interpersonal skills and 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.
Applicants must possess or obtain authorization to work in the United States.

Nice To Haves

Master's or PhD degree in a biological science or chemical or bioprocess engineering.
Expert-level competency in validation of processes, equipment, cleaning procedures, software, and computerized systems.
Solid knowledge of Zoetis biological and biopharmaceutical products.

Responsibilities

Ensure VMRD production facilities and transfers of newly developed or improved biological and biopharmaceutical products and processes comply with applicable USDA, EU, FDA, Zoetis, and destination-country requirements.
Work with VMRD Development Science & Technology colleagues on scale-up, technical transfers, and coordination of regulatory issues.
Serve as a QA consultant for development, clinical, and VICH batches or serials.
Provide VMRD colleagues with regulatory documents and manufacturing quality and compliance resources.
Review new product master batch records, manufacturing documents, and analytical documents for accuracy, completeness, and compliance with Outlines of Production and submissions; provide QA approval.
Review and approve validation protocols and reports.
Work with VMRD, VMRA, and GMS in preparing and reviewing Outlines of Production and submissions.
Conduct and review deviation investigations related to manufacturing, packaging, product testing, sterility assurance, and other GMP functions.
Guide and oversee root-cause identification, corrective and preventive actions (CAPAs), and CAPA effectiveness checks.
Evaluate and approve changes to manufacturing and packaging equipment and processes, testing, IT systems, and other GMP documents and programs.
Help ensure suppliers of raw materials and components procured by Lincoln Operations maintain processes, systems, and facilities that provide quality products.
Coordinate and participate in audits and pre-approval surveys of key and potential suppliers as necessary.
Participate in teams and make recommendations to maintain regulatory compliance within Lincoln Operations.
Advise management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
Maintain contemporary technical and regulatory knowledge relevant to vaccine and biopharmaceutical development.
Contribute technical guidance, informal leadership, mentoring, and coaching within the workgroup or team; may supervise colleagues.