12 часов назад
Supply Operations Quality Manager/ Market Lead Uruguay/ Paraguay (Pharmaceutical Quality)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Supply Operations Quality Manager/ Market Lead Uruguay/ Paraguay (Pharmaceutical Quality): Leading Pfizer’s quality management system and compliant product supply across Uruguay and Paraguay with an accent on GDP/GMP compliance, regulatory requirements, audits, and vendor oversight. Focus on managing quality events, preparing inspections, assessing supply-chain risks, and driving continuous improvement across local operations.
Location: Montevideo, Uruguay; hybrid work arrangement. The role supports quality operations for Uruguay and Paraguay.
Company
develops and delivers pharmaceutical products with a focus on patient safety, scientific quality, and risk-based compliance.
What you will do
- Lead and maintain the Quality Management System for Uruguay and Paraguay.
- Act as the primary quality contact for local stakeholders, regulatory authorities, vendors, distributors, and external partners.
- Prepare for and manage health authority inspections, internal audits, RQA audits, and self-inspections.
- Manage deviations, investigations, CAPAs, product quality complaints, and management notifications.
- Monitor quality metrics, conduct Quality Management Reviews, identify risks, and drive continuous improvement.
- Provide quality oversight for suppliers, warehouses, logistics providers, distributors, recalls, withdrawals, and shortage-management activities.
Requirements
- Bachelor’s degree in Chemistry or Pharmaceutical Chemistry and at least 7 years of experience in the pharmaceutical or related industry.
- Significant experience in Quality Operations, Quality Assurance, GDP/GMP compliance, and Quality Systems.
- Knowledge of GxP regulatory requirements for Uruguay and Paraguay.
- Experience managing regulatory inspections and audits, as well as vendor oversight activities.
- Computer skills in MS Office and enterprise systems such as SAP, eQMS, QDocs, or equivalent.
Nice to have
- Master’s degree with relevant pharmaceutical experience.
- Knowledge of GxP regulatory requirements for Argentina.
- Strong analytical, problem-solving, interpersonal, time-management, and collaboration skills.
Culture & Benefits
- Hybrid work arrangement.
- Work across Commercial, Regulatory Affairs, Global Supply Chain, Medical, Legal, and external stakeholder groups.
- Quality-focused environment centered on patient safety, compliance, adaptability, and continuous improvement.
- Equal employment opportunity for employees and applicants.
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