Supply Operations Quality Manager/ Market Lead Uruguay/ Paraguay

Use Your Power for Purpose

Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Your contributions ensure that our high standards are met, fostering a culture that is both adaptable and forward-thinking. Join us in our mission to make a difference through dedication and excellence in every aspect of our work.

What You Will Achieve

In this role, you will:

• Lead and maintain the Pfizer Quality Management System (QMS) for Uruguay and Paraguay, ensuring compliance with Pfizer standards, GDP/GMP requirements, and local regulations.

• Serve as the primary SOQ representative and quality contact for local stakeholders, regulatory authorities, and external partners.

• Ensure inspection readiness and lead the preparation, coordination, and management of Health Authority inspections, Pfizer internal audits, RQA audits, and self-inspections.

• Manage quality events, including deviations, investigations, CAPAs, product quality complaints, and Notification to Management (NtM) activities.

• Monitor quality metrics and KPIs, identify trends and risks, and drive continuous improvement initiatives.

• Perform Quality Management Reviews and ensure timely closure of quality commitments and compliance actions.

• Ensure implementation and assessment of new regulatory requirements and Pfizer quality standards applicable to Uruguay and Paraguay.

• Provide quality oversight for local vendors, warehouses, logistics service providers, distributors, and other service providers operating under SOQ responsibility.

• Support market actions, product recalls, withdrawals, shortage management, and execution of QRT-related activities.

• Oversee supplier qualification, quality agreements, vendor performance reviews, and risk-based quality assessments.

• Drive quality culture and ensure appropriate GxP training and awareness across the organization.

• Partner with Commercial, Regulatory Affairs, Global Supply Chain, Medical, Legal, and external stakeholders to support compliant business operations and uninterrupted product supply.

• Act as the local quality leader responsible for protecting patients, maintaining Pfizer's licenses to operate, and ensuring the quality and compliance of products distributed in Uruguay and Paraguay.

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree in Chemistry, Pharmaceutical Chemistry, with 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 in the GxP regulation requirements for Uruguay and Paraguay.

• Experience managing regulatory inspections and audits.

• Experience leading vendor oversight activities.

• Computer skills in MS Office and enterprise systems like SAP, eQMS, QDocs, or equivalent.

Bonus Points If You Have (Preferred Requirements)

• Master’s degree with relevant pharmaceutical experience.

• Knowledge in the GxP regulation requirements for Argentina (considering interfaced activities with this market).

• Strong analytical and problem-solving skills.

• Ability to manage time and resources effectively.

• Strong interpersonal skills and the ability to work collaboratively with cross-functional teams.

Work Location Assignment: Hybrid. Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Quality Assurance and Control