Manager - Product Development Quality

Zoetis; Lincoln (NE); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Zoetis in Lincoln, NE seeks a senior QA/regulatory professional to ensure the transfer and release of biologics/biopharmaceuticals, maintaining compliance with US/EU/FDA standards and Zoetis policies.

You will lead regulatory coordination, review records, validate protocols, audit suppliers, and mentor teams across development, clinical, and manufacturing stages.

Qualifikationen

• 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.
• Advanced knowledge of vaccine/biopharmaceutical development and GMP compliance.

Aufgaben

• Ensure VMRD facilities and transfers comply with USDA, EU, FDA, Zoetis quality standards and destination country regulations.
• Serve as QA consultant for development, clinical, and VICH batches; provide regulatory documents and quality resources.
• Review master batch records, manufacturing and analytical documents for compliance and provide QA approval.
• Review/approve validation protocols; collaborate on Outlines of Production/submissions.
• Conduct and review deviation investigations; identify root cause, CAPAs, and effectiveness checks.
• Approve changes to manufacturing equipment, processes, testing, IT systems, and GMP documents.
• Coordinate audits/pre-approval surveys of suppliers to ensure quality inputs.
• Maintain regulatory compliance within Lincoln Operations; advise on deficiencies and actions.
• Maintain contemporary knowledge in vaccine/biopharmaceutical regulatory disciplines.

Kenntnisse

Quality Assurance

Regulatory Affairs

GMP Compliance

CAPA & Deviation

Auditing

Regulatory Documentation

Vaccine/Biopharma Knowledge

Ausbildung

Bachelor's degree in biological/pharmaceutical sciences

15+ years biology/pharma experience

Tools

N/A

Jobbeschreibung

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.

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.

About Zoetis

At Zoetis, our purpose is to nurture the 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.

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