Contractor Quality Lead

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Serve as the virtual internal Quality representative for Contract Manufacturing Organizations.

• Ensure that external partners adhere to Zoetis Quality Standards and comply with GMP and regulatory requirements.

• Provide Quality oversight for designated CMOs and maintain robust, effective Quality systems.

• Assess Quality-related investigations and support initiatives for continuous improvement.

• Act as a liaison between Zoetis and CMOs concerning audits, Quality Agreements, deviations, changes, complaints, and regulatory commitments.

• Identify and mitigate Quality and compliance risks.

• Negotiate, implement, and periodically review Quality Agreements.

• Evaluate and coordinate product-related changes and regulatory assessments.

• Review deviations, determine necessary actions and escalation levels, and ensure follow-up and resolution.

• Oversee CMO CAPAs, track progress, verify effectiveness, and escalate any delays or systemic issues.

• Implement lot disposition processes and conduct annual risk assessments for product release.

• Manage external market complaints, monitor trends, and address recurring issues.

• Supervise Quality activities involving suppliers and Zoetis-tolled materials.

• Review Annual Product Reviews, stability reports, artwork, and regulatory submissions.

• Assess and facilitate routine CMO audits and independently conduct audits when qualified.

• Monitor inspections, CAPA responses, regulatory activities, and the outcomes of inspections.

• Ensure precise and timely documentation in Veeva Vault CMO Tool and TrackWise.

• Manage stability commitments, OOS escalation, temperature excursion assessments, and stability impact evaluations.

• Enhance the Zoetis Global External Manufacturing Quality System and spearhead cross-functional Quality improvement initiatives.

⛳️ Requirements

• Bachelor’s or Master’s degree in Pharmaceutical Science, Microbiology, Chemistry, or an equivalent scientific discipline.

• Significant experience in a regulated industry.

• Relevant experience in Quality Assurance, Quality Control, Manufacturing, Auditing, Engineering, R&D, or Regulatory Affairs.

• Proficient in English.

• Proficient in the local language.

• Knowledge of additional regional languages is a plus.

• Familiarity with a diverse range of products.

• Understanding of global regulatory requirements.

• Experience across a varied product portfolio is preferred.

• Experience in the Animal Health industry is ideally preferred.

• Willingness to travel up to 20%.

• Working knowledge of manufacturing processes, validation, test methods, and regulatory requirements.

• Capability to assess investigations, root causes, CAPAs, deviations, changes, complaints, audits, and regulatory commitments.

• Proficient in using Veeva Vault CMO Tool and TrackWise.

• Eligibility for independent audits under the Zoetis Auditor Certification Program when qualified.

🏝️ Benefits

• Full-time regular colleague position.

• Collaborative, high-performing work environment.

• Opportunities to learn and grow.

• Diverse and exciting career opportunities.

• Opportunity to make a difference in the global animal health industry.