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
- 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
- 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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