Contractor Quality Lead

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

📋 Description

• Serves as the virtual internal Quality representative for Contract Manufacturing Organizations (CMOs).

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

• Provides Quality oversight for designated CMOs, ensuring robust and effective Quality systems.

• Assesses Quality-related investigations and supports initiatives for continuous improvement.

• Communicates with CMOs regarding audits, Quality Agreements, deviations, changes, complaints, and regulatory commitments.

• Identifies and mitigates Quality and compliance risks.

• Negotiates and reviews Quality Agreements.

• Evaluates and manages product-related changes and their implementation timelines.

• Analyzes significant CMO deviations and determines appropriate actions and escalation levels.

• Oversees CMO Corrective and Preventive Actions (CAPAs), tracking progress, verifying effectiveness, and escalating any delays or systemic issues.

• Implements lot disposition processes and conducts annual risk assessments for Zoetis products.

• Manages external market complaints in collaboration with the Pharmacovigilance team and monitors complaint trends.

• Acts as the Quality Single Point of Contact for Zoetis-tolled materials and supplier Quality activities.

• Reviews Annual Product Reviews, stability reports, and corrective and preventive actions.

• Coordinates and participates in CMO audits, including independent audits when qualified.

• Assists with regulatory activities and submissions.

• Monitors BoH inspections and communicates outcomes and necessary actions.

• Reviews draft artwork for accuracy.

• Documents CMO activities in Veeva Vault CMO Tool and TrackWise.

• Oversees stability commitments, Out of Specification (OOS) escalation, temperature excursion assessments, and impact evaluations.

• Contributes to the enhancement of the Zoetis Global External Manufacturing Quality System.

• Leads cross-functional Quality improvement initiatives and drives continuous enhancement.

⛳️ Requirements

• Bachelor’s or Master’s degree in Pharmaceutical Science, Microbiology, Chemistry, or a related scientific field.

• Extensive experience in a regulated industry.

• Relevant background in Quality Assurance, Quality Control, Manufacturing, Auditing, Technical functions such as Engineering or 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 standards.

• Experience across a varied product portfolio is preferred.

• Experience in the Animal Health industry is ideally preferred.

• Willingness to travel up to 20%.

• Must be legally authorized to live and work in Ireland.

🏝️ Benefits

• Competitive salary.

• Bonus opportunities.

• 25.5 days of holiday per year in addition to public holidays.

• A defined contributory pension plan.

• Private medical insurance for yourself and your family.

• Empowered flexible working arrangements.

• Healthcare and retirement savings benefits.

• Various benefits, policies, and programs designed to support employee well-being, including health, financial wellness, and family and lifestyle resources.