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 teams 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 evaluate overall risks and address adverse trends to ensure / enhance compliance.

Facilitate Pfizer Manufacturing Supplier Quality Assessment audits define improvement plan and ensure timely closure of action

Quarantine Alert Notices : Manage Quarantine Alert Notices received from Primary Logistic locations. Verify whether product lots remains at DC / LSP and if applicable instruct LSP to place the product on hold. Notify Primary Logistic Location and PGS Site / COQA of quantity of product still within Pfizer control and execute product disposition instructions accordingly.

Development and Maintenance of Consistent Quality Culture : Collect and report quality performance data and metrics for the PCO via regular Management Quality Review process and communicate to SOQ Leadership. Deliver ongoing education to relevant PCO functional groups to strengthen awareness and understanding of requirements and foster the Quality Culture

Suppliers and Customers Qualification : Ensure suppliers and customers are qualified in accordance with GDP-requirements. Provides local support upon request to the RP for the customers qualifications.

Here Is What You Need (Minimum Requirements)

Minimum B.S. in Pharmacy Engineering Science or related discipline.

A minimum of 10 years in the pharmaceutical industry preferably in a quality role.

Extensive people management and talent development expertise

Deep understanding of GMPs / GDPs

Effective communication skills both written and verbal

Strong interpersonal skills

Ability to juggle multiple projects simultaneously

Robust problem-solving capabilities

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including : the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Bonus Points If You Have (Preferred Requirements) :

Masters degree and relevant pharmaceutical experience

Possesses technical and quality expertise aligned with management expectations.

Demonstrates sound judgment and makes effective quality decisions under pressure.

Proficient in computer applications and digital tools.

Exceptional negotiation abilities with strong effective communication skills.

Skilled in technical writing and reporting.

Experienced in current Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).

Proven experience in Quality Management for warehouse operations contractor oversight and / or PGS Site operations.

Proven experience in establishing and developing new organizational structures.

Highly self-motivated and comfortable working independently.

Demonstrated cultural awareness and ability to navigate cross-cultural environments.

Skilled in leading and collaborating within cross-functional teams.

Track record of driving continuous improvement while balancing efficiency and effectiveness.

Physical / Mental Requirements

N / A No specific requirements

Non-Standard Work Schedule Travel or Environment Requirements

Some travel may be required to support business priorities.

Work Location Assignment : Hybrid

Other Job Details

• Last Date to Apply : December 5 2025

The annual base salary for this position ranges from $169700.00 to $282900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver / parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and / or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.

EEO & 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 disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

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Quality Assurance and Control

Key Skills

Fitness,AXA,Council,Cleaning,Data Analysis

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 169700 - 282900