Contractor Quality Lead

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🔥 0 minutes ago

🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Logo of Zoetis

Zoetis

10,000+ employees

Founded 1952

🏥 Healthcare

🍽️ Food & Beverage

🏭 Manufacturing

Healthcare • Food & Beverage • Manufacturing

Zoetis is the world's leading animal health company, committed to nurturing the world and humankind by advancing care for animals. With over 70 years of innovation, Zoetis develops a broad portfolio and pipeline of medicines, vaccines, diagnostics, and technologies that span a continuum of care to predict, prevent, detect, and treat animal illnesses. Operating in more than 100 countries, the company supports livestock farmers, veterinarians, and pet owners around the globe. Zoetis is driven by science and their shared passion for the human-animal bond, aiming to create a more sustainable and healthier world for all.

📋 Description

• Act as the virtual internal Quality representative for Contract Manufacturing Organizations • Ensure external partners meet Zoetis Quality Standards and comply with GMP and regulatory requirements • Provide Quality oversight for assigned CMOs and ensure robust, effective Quality systems • Evaluate Quality-related investigations and support continuous improvement initiatives • Liaise between Zoetis and CMOs regarding audits, Quality Agreements, deviations, changes, complaints, and regulatory commitments • Identify and mitigate Quality and compliance risks • Negotiate, implement, and periodically review Quality Agreements • Assess and coordinate product-related changes and regulatory assessments • Evaluate deviations, determine actions and escalation levels, and ensure follow-up and resolution • Oversee CMO CAPAs, track progress, verify effectiveness, and escalate delays or systemic issues • Apply lot disposition processes and perform annual risk assessments for product release • Manage external market complaints, monitor trends, and address recurring issues • Manage 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 perform audits when qualified • Monitor inspections, CAPA responses, regulatory activities, and inspection outcomes • Ensure accurate, 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 lead 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 • Fluent in English • Fluent in the local language • Knowledge of additional regional languages is desirable • Knowledge of a broad range of products • Understanding of global regulatory requirements • Experience across a diverse product portfolio is preferred • Animal Health industry experience is ideally preferred • Willingness to travel up to 20% • Working knowledge of manufacturing processes, validation, test methods, and regulatory requirements • Ability to assess investigations, root causes, CAPAs, deviations, changes, complaints, audits, and regulatory commitments • Ability to use 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

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