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

• Acts as the virtual internal Quality representative for Contract Manufacturing Organizations (CMOs) • Ensures external partners meet Zoetis Quality Standards and comply with GMP and regulatory requirements • Provides Quality oversight for assigned CMOs and ensures robust and effective Quality systems • Evaluates Quality-related investigations and supports continuous improvement initiatives • Liaises with CMOs regarding audits, Quality Agreements, deviations, changes, complaints, and regulatory commitments • Identifies and mitigates Quality and compliance risks • Negotiates and reviews Quality Agreements • Assesses and manages product-related changes and implementation timelines • Evaluates significant CMO deviations and determines actions and escalation levels • Oversees CMO CAPAs, tracks progress, verifies effectiveness, and escalates delays or systemic issues • Applies lot disposition processes and performs annual risk assessments for Zoetis products • Manages external market complaints with the Pharmacovigilance team and monitors complaint trends • Acts as 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 • Supports regulatory activities and submissions • Monitors BoH inspections and communicates outcomes and actions • Reviews draft artwork for accuracy • Records CMO activities in Veeva Vault CMO Tool and TrackWise • Oversees stability commitments, OOS escalation, temperature excursion assessments, and impact evaluations • Supports enhancement of the Zoetis Global External Manufacturing Quality System • Leads cross-functional Quality improvement initiatives and drives continuous improvement

🎯 Requirements

• Bachelor’s or Master’s degree in Pharmaceutical Science, Microbiology, Chemistry, or equivalent scientific discipline • Significant experience in a regulated industry • Relevant experience in Quality Assurance, Quality Control, Manufacturing, Auditing, Technical functions such as Engineering or 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% • Must be legally eligible to live and work in Ireland

🏖️ Benefits

• competitive salary • bonus • 25.5 days holiday per annum plus public holidays • a defined contributory pension plan • private medical insurance for you and your family • empowered flexible working • healthcare and retirement savings benefits • benefits, policies and programs to support employee well-being, including health and financial wellness and family and lifestyle resources

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