QA & Compliance Leader - Biopharma Product Development

Zoetis Inc; Lincoln (NE); On-site; USD 95,000 - 150,000; Full time

Job summary

Zoetis in Lincoln, NE seeks an experienced QA & Compliance professional to ensure transfer and regulatory compliance of new biological/biopharmaceutical products. You will partner with DST teams on scale-up and regulatory issues, and approve master records, validation reports, and CAPAs.

Ideal candidates possess a Bachelor’s degree with extensive QA/Regulatory experience, strong cGMP knowledge, and excellent written and verbal communication skills to navigate multi-country regulatory

Qualifications

• 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.
• Experience with Quality Assurance auditing, current Good Manufacturing Practices (cGMP), and quality systems.
• 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.

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 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.

Skills

QA auditing

cGMP

Regulatory affairs

Process validation

Lean principles

Quality systems

Analytical skills

Communication

Cross-functional collaboration

Education

Bachelor’s degree

Master’s or PhD preferred

Job description

Zoetis in Lincoln, NE seeks an experienced QA & Compliance professional to ensure transfer and regulatory compliance of new biological/biopharmaceutical products. You will partner with DST teams on scale-up and regulatory issues, and approve master records, validation reports, and CAPAs.

Ideal candidates possess a Bachelor’s degree with extensive QA/Regulatory experience, strong cGMP knowledge, and excellent written and verbal communication skills to navigate multi-country regulatory