Supply Operations Quality Manager – Uruguay & Paraguay

About the role

Join Pfizer’s quality team to lead the Supply Operations Quality function for Uruguay and Paraguay. You will ensure compliance with Pfizer standards, GDP/GMP requirements, and local regulations while protecting patient safety and product integrity.

Key responsibilities

• Lead and maintain the Pfizer Quality Management System (QMS) for Uruguay and Paraguay.
• Serve as the primary SOQ representative for local stakeholders, regulatory authorities, and external partners.
• Prepare for and manage Health Authority inspections, internal audits, RQA audits, and self‑inspections.
• Manage quality events including deviations, investigations, CAPAs, product complaints, and Notification to Management activities.
• Monitor quality metrics, identify trends and risks, and drive continuous‑improvement initiatives.
• Oversee vendor qualification, quality agreements, and risk‑based assessments for local vendors, warehouses, logistics providers, and distributors.
• Support market actions such as product recalls, withdrawals, shortage management, and QRT‑related activities.
• Partner with Commercial, Regulatory Affairs, Global Supply Chain, Medical, Legal, and external stakeholders to ensure uninterrupted product supply.

Required profile

• Bachelor’s degree in Chemistry, Pharmaceutical Chemistry or related field.
• Minimum 7 years of experience in the pharmaceutical industry, specifically in Quality Operations, Quality Assurance, GDP/GMP compliance, and quality systems.
• Knowledge of GxP regulatory requirements for Uruguay and Paraguay.
• Proven experience managing regulatory inspections and audits.
• Experience leading vendor oversight activities.
• Proficiency with MS Office and enterprise systems such as SAP, eQMS, QDocs or equivalents.

Required skills

• MS Office
• SAP
• eQMS
• QDocs (or equivalent quality management software)