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
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