Manager - Product Development Quality

Zoetis•Lincoln, NE

About The Position

Provide quality assurance and compliance expertise for Veterinary Medicine Research & Development (VMRD), supporting the design, execution, and transfer of new biological and biopharmaceutical products to help achieve department and site objectives. The role ensures VMRD production facilities and product or 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; serve as a QA consultant for development, clinical, and VICH batches or serials; and provide regulatory documents and manufacturing quality and compliance resources. Review and approve product records, manufacturing and analytical documents, validation protocols and reports, and regulatory submissions. Conduct and review deviation investigations, guide root-cause analysis and CAPAs, and evaluate changes to manufacturing, packaging, testing, IT systems, and GMP programs. Support supplier assurance through audits and pre-approval surveys, participate in teams to maintain regulatory compliance, and advise management of regulatory deficiencies and appropriate actions. The position requires advanced technical knowledge, independent work across multiple assignments, sound judgment in moderately complex and ambiguous situations, collaboration and informal leadership, and mentoring or coaching colleagues. The manager may supervise colleagues and contribute to short-term operational goals and functional or project-team decisions.

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 within 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.

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 new or improved biological and biopharmaceutical products and processes comply with applicable USDA, EU, FDA, Zoetis, and destination-country requirements.
Work with Development Science & Technology colleagues on scale-up, technical transfers, and regulatory issue coordination.
Serve as a QA consultant for development, clinical, and VICH batches or serials, and provide 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 to prepare and review Outlines of Production and submissions.
Conduct and review deviation investigations involving manufacturing, packaging, product testing, sterility assurance, and other GMP functions.
Guide 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 supplier processes, systems, and facilities maintain the quality of raw materials and components procured by Lincoln Operations, coordinating and participating in audits and pre-approval surveys as needed.
Participate in teams and make recommendations to maintain regulatory compliance within Lincoln Operations.
Advise management of regulatory deficiencies and recommend appropriate actions when products do not meet Zoetis or government requirements.
Maintain contemporary knowledge of technical and regulatory disciplines relevant to vaccine and biopharmaceutical development.
Develop or adapt processes, hypotheses, techniques, and technology to address technical or process needs.
Contribute to team decisions, facilitate agreements, support team goals, and contribute to functional or line strategic direction when appropriate.
Provide formal or informal mentoring and coaching within the workgroup or team; may supervise colleagues.
Identify and develop activities or projects that support short-term operational goals.