Supply Operations Quality Market Lead – United States

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering high-quality, safe, and effective products to patients. Our adaptable, innovative, and customer-focused quality culture ensures that your contributions in development, maintenance, compliance, or analysis through research programs will directly benefit patients. Your leadership will help us continue to meet and exceed the requirements of Pfizer and regulatory authorities, ensuring the quality of our products and fostering a culture of continuous improvement and innovation.

What You Will Achieve

In this role, you will:

• Manage a team of SOQ professionals to ensure an appropriate and sustainable Product Quality System and Quality Culture is established for the new US Market Quality team to ensure compliance with Pfizer and Regulatory Authority expectations. 

• Ensure the effective investigation and resolution of all product quality issues discovered or originating in the US market and for ensuring the team’s interaction with the relevant stakeholders (such as Regulatory Affairs, Global Supply Chain) and PGS on such issues.

• Fulfill the Responsible Person (RP) role for the Pfizer Overseas Limited Liability Company (POLLC) as per Good Distribution Practice (GDP) legislation – if applicable.

The SOQ US Market Quality Lead is responsible for leading and developing the SOQ US Market Quality team while supporting the global goals of the Global Supply Chain (GSC) and External Supply Quality organization.  This individual ensures alignment with Country and Regional Management on SOQ and compliance activities for the US market. Other key responsibilities are partnering with DSRT on Drug Shortages and communications with FDA Drug Shortage Staff and coordinating between GSC and PGS Manufacturing Sites to maintain continuity of supply for the US market.

• Deviation Management (in conjunction with the PGS Quality Operations): Investigate deviations from Product Quality and Compliance requirements that occur within the responsibility of the US market and agrees and tracks preventive/corrective actions. Provides input from quality perspective to Commercial for the resolution of customer complaints related to distribution activities.

• Notification to Management: Inform PGS Quality Operations Management of significant deviations and complaints. Attend Area Quality Review Teams (AQRT) meetings, as relevant SOQ and provides Executive Summary Report. Ensures the local implementation of actions identified during AQRT meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.

• Quality Management System: Ensure timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO. Monitor and analyze key quality performance indicators, identify trends and recommend corrective actions. Assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes is applicable

• Local Product Disposition: Oversee local product release under the US distribution license, ensuring compliance with the applicable regulations and procedures, prior to distribution or sale within country. Make final disposition decisions of returned, rejected, recalled or falsified products. Define requirements for returning products back to saleable stock and coordinate actions with logistics and distribution center. Lead and execute recall operations for medicinal products. Initiate appropriate actions if counterfeit products are identified.

• Inspections and Internal Audit: Supports preparation and coordination of GMP/GDP Regulatory Agency inspections of the US market legal entity (Pfizer Overseas Limited Liability Company (POLLC). Lead internal Pfizer audits of Product Quality and Compliance (GMP/GDP), collaborating with local functions to define and implement corrective action plans

• Subcontracted activities with GMP/GDP impact: Approve subcontracted activities impacting GMP/GDP compliance and establish, negotiate and maintain current Quality Agreements with GMP/GDP contractors (e.g. Logistics Service Providers (LSPs), relabeling/repackaging contractors). Oversees quality operations, including but not limited to:

  • Contractor Assessment and Approval: Ensure GMP/GDP contractors have been formally assessed and approved.

  • Deviation Management: Assess significant deviations affecting product quality, agree on corrective actions and initiate “Notification to Management” process when required

  • Quality System Oversight: Conduct site visits to review quality systems, performance and implement continuous improvement plan

  • Metrics and Risk Management:   Monitor quality metrics, e