Coordinador de Operaciones de Calidad de la Afiliada

Overview States considered: Ciudad de México Role Description The Affiliate QO Coordinator is located within Mexico Zoetis Country Office for specific markets responsibilities relating to oversight of product quality activities and associate GMP/GDP activities. In addition, he/she will carry out all supporting activities required to meet legally defined requirements of the licencing bodies. He/She is responsible for the Quality Management System (QMS), ensuring its use and its ongoing suitability for the business and GMS. The Affiliate QO Coordinator is also responsible for developing and maintaining the site Quality Manual in Veeva Vault, site quality system policies, procedures and quality records to comply with local QMS requirement and harmonized with the global QMS. The Affiliate QO Coordinator will oversee Quality matters and provide expert advice and direction to the business and the country Leadership Team. This function supplements any local or statutory Quality activities or requirements. The holder of this role is part of the Regulatory and Quality Leadership Team, helping to manage the business area’s functioning, developing the strategic focus for the team and generate new ideas to move the business forward, improve efficacy and maintain legal compliance. Main Responsibilities Quality Assurance Quality System Implementation & Management Oversight Be the Affiliate QO for Mexico, CAMCar and Colombia; the nominated contact person located in Mexico, for any Quality related issues as required by Zoetis GMS Monitor, review the performance of the QMS with SCL QO. Act to assure its maintenance, continued suitability and implement any improvements needed Ensure colleagues are appropriately trained on all necessary Routine in Country Quality Activities and deviation management Investigation and resolution of Product Quality and Compliance Related Issues Temperature excursion escalation Stop distribution, Recalls Change management Contractor Quality Oversight (where managed by Zoetis Mexico, CAMCar and Colombia Markets) Monitor and Communicate local MoH Requirements Ensuring audit readiness and hosting GQCA auditors on country Zoetis Affiliates audits. Development and Maintenance of Consistent Quality Culture Perform QM setup and approval for SAP Item Master setup using MDG tool Perform QA releases of Zoetis Products to the market, using SAP and corresponding systems in Mexico and Colombia. Ensure all SAP actions are planned, monitored and executed for the business. Attend Quality meetings for critical product quality issues, representing the businesses Prepare required documentation for product quality complaints that require Quality/ market action Lead the Zoetis action to address product quality or compliance issues identified when the product is distributed in the market. Audit suppliers to assure continued fitness for provision of goods and services to Zoetis. Compliance Maintain high standards of business conduct and compliance, adhering particularly to Pharmacovigilance Policy, Global Vet Policy, Zoetis Quality standards and the QMS, Zoetis values, travel & expenses policy and local codes of practice Relationships Accountable for establishing appropriate professional partnerships, agreements and communication processes with in-market teams especially, Supply Chain and Logistics, Regulatory, SCL QO, commercial service to ensure continuously improving quality performance service levels and objectives are achieved in alignment with approved budgets. Works closely with the team of SCL QO in the Latin American Drives agreed implementation of changes that enhance performance, productivity and cost. Qualifications (Training, Education & Prior Experience) Education: Bachelor’s degree in a Life Science, Pharmaceutical Science, Veterinary, Chemistry, Biology or equivalent IT literate. Able to use standard business software, communication tools and quality management systems Experience: Proven Quality Management experience (5+ years) in Animal Health/Human Health pharmaceutical environment Must be proficient in the knowledge of current Good Distribution Practices (GDP), ISO Quality Requirements, WHO and applicable regional pharmaceutical legislation and regulations Experience of the workings and practises of industry bodies e.g., SADER, COFEPIRS, ICA, etc. Problem solving in a volatile environment Working knowledge of pharmaceutical product transportation channels and LSPs Demonstrated ability to operate successfully in a matrix organization Skills Analytically minded with strong attention to detail and problem-solving skills Exceptional communication skills; written and verbal Exceptional relationship management, interpersonal skills and influencing abilities Effective time management, prioritisation, and organisational abilities Works effectively to deadlines and under time pressures Multi-tasking skills, ability to meet multiple and overlapping deadlines Strong business and financial acumen with a keen commercial mind. Other Commentaries English level: Bilingual efficiency (Spanish and English) as a minimum Preferred place of residence: Ciudad de México Full time #J-18808-Ljbffr