GSC Quality Management System Lead

Pfizer • New York City, NY

3d

About The Position

The GSC Quality Management System (QMS) Lead is accountable for the operational deployment, lifecycle management, and continuous improvement of Pfizer’s Quality Management System for Global Supply Chain (GSC), particularly Global Logistics. The role ensures GSC activities comply with applicable regulatory requirements, Good Distribution Practices, corporate quality standards, and approved policies, procedures, work instructions, and forms. It leads quality oversight across Logistics Vendor Management, Quality Risk Management, inspection readiness, QMS performance, and remediation, and serves as a primary escalation point for significant GSC QMS compliance issues and risks.

Working across Global Logistics, Quality Operations, Regulatory, and other partner functions, the Lead embeds quality in operational decision-making and promotes a culture focused on product quality, patient safety, quality, and compliance to support reliable supply. The role develops and sustains an effective team through recruitment, onboarding, training, and colleague development. Non-QMS processes, Compliance, Enterprise Risk strategy, the GSC Risk Register, and overall performance management, vendor management, and continuous improvement processes are owned by the GLRC Lead. The QMS Lead partners closely with the GLRC Lead to integrate risk management, audit programs, and risk assessment and prioritization for local and global logistics operations.

The position reports to the VP Global Logistics and is a member of the GL Leadership Team. It supports and partners with the Leadership Team to drive the T4 Blueprint, sponsors selected initiatives, and participates in the T4 Leadership ecosystem. The role leads market compliance subject-matter experts, provides governance and expertise across GSC and Global Logistics QMS processes, supports regulatory inspections and audits, drives provider quality governance and continuous improvement, and develops organizational capability through training, coaching, and talent development.

The role requires flexibility to work across global time zones and international travel for internal and external meetings, approximately 20–30% of the role and higher in the first year. The position is posted in multiple locations. U.S. candidates must be authorized to work in the United States; work visa sponsorship is not available.

Requirements

• Bachelor’s degree and at least 12 years of experience; or a master’s degree and at least 10 years of experience; or a PhD and at least 7 years of experience.
• Significant experience in a regulated pharmaceutical, biotechnology, healthcare, manufacturing, distribution, or logistics environment.
• Demonstrated knowledge of quality management systems, regulatory compliance, and quality risk management.
• Practical experience with deviations, investigations, CAPAs, change control, internal audits, inspection readiness, and Board of Health inspections.
• Experience working with logistics, warehousing, transportation, distribution, or external service providers.
• Demonstrated ability to lead complex cross-functional initiatives and influence senior stakeholders.
• Strong analytical, communication, facilitation, and problem-solving skills.
• Ability to work flexible hours spanning global time zones.
• Ability to travel internationally for internal and external meetings, approximately 20–30% of the role and higher in the first year.
• Candidates must be authorized to work in the U.S. by any employer; U.S. work visa sponsorship is unavailable.

Nice To Haves

• Advanced degree or relevant professional qualification in Quality, Supply Chain, Logistics, Pharmacy, Science, Engineering, or Business.
• Familiarity with GDP/GMP execution requirements and operations experience overseeing logistics service providers or third parties.
• Formal training or certification in quality management, auditing, risk management, Lean, or Six Sigma.
• Experience managing quality oversight of third-party logistics providers and/or internal manufacturing or in-house distribution center operations.
• Experience operating in a regional or global matrix organization.
• Global or regional project management experience and certification.

Responsibilities

• Develop, deploy, and maintain the GSC QMS strategy and implementation roadmap.
• Own the Warehousing & Distribution Global Policy in alignment with the GLRC Lead and GSC Risk and Compliance Policy.
• Ensure the development, deployment, adoption, lifecycle management, and continuous improvement of W&D procedures, work instructions, guidance documents, and forms in compliance with corporate quality requirements and regulatory expectations.
• Ensure GSC operations adopt applicable non-W&D elements of Pfizer’s QMS.
• Assess learning needs, translate them into training curricula, and ensure colleagues complete assigned compliance training using the NexGen Academy.
• Translate corporate quality and regulatory expectations to logistics vendors through Quality and Technical Agreements.
• Establish governance forums to track QMS development, deployment, adoption, lifecycle management, and improvement; assess QMS effectiveness and maturity and identify standardization, simplification, and improvement opportunities.
• Provide oversight of compliance with Good Distribution Practices, license requirements, corporate quality standards, and relevant local regulations.
• Maintain quality oversight of warehousing and distribution operations and monitor changing quality and GDP regulatory expectations, coordinating necessary QMS updates.
• Ensure logistics operations are inspection-ready and quality records are accurate, complete, controlled, and readily retrievable.
• Support regulatory inspections, internal audits—including RQA audits of vendors and Pfizer Country Offices—and corporate quality reviews in conjunction with the GLRC Lead.
• Coordinate responses to GSC-related observations and manage QMS remediation commitments.
• Lead the team of Market Compliance SMEs at Anchor and Cluster levels, partnering with in-market Logistics operations leads.
• Lead local adoption of Revolution GSOPs, GWIs, and BGDs; ensure milestones, adoption, auditing, and process confirmation are completed.
• Work with local process owners and operational leaders to translate new or revised GSC QMS requirements into sustainable practices, and provide guidance, training, and coaching.
• Establish and maintain a consistent approach to identifying, assessing, mitigating, and monitoring quality risks in alignment with the GLRC Lead.
• Evaluate risks associated with GSC processes, distribution lanes, service providers, facilities, systems, and operational changes; establish controls, owners, actions, and review mechanisms.
• Escalate unresolved QMS risks through enterprise risk governance and GSC risk and compliance reviews; provide evidence-based recommendations and track mitigation plans through sustainable closure.
• Provide governance and subject-matter leadership for QMS processes including Quality Management Review, vendor management, Quality and Technical Agreements, internal audits, inspection readiness, Quality Risk Management, deviations, CAPA, change control, document and records management, and training compliance.
• Maintain a quality governance framework for logistics service providers and relevant vendors, with defined expectations, responsibilities, escalation pathways, and performance reviews.
• Partner with the GLRC Lead, Quality, Operations, and Procurement to incorporate logistics quality and technical requirements into provider selection, onboarding, and ongoing governance.
• Monitor provider quality performance, recurring events, audit outcomes, remediation plans, and systemic or emerging risks.
• Maintain Logistics QMS effectiveness and quality-system performance indicators; monitor trends, systemic issues, recurring events, and increasing compliance risks.
• Track action closure, remediation effectiveness, and overall QMS health, leveraging the Risk Register for major systemic trends and issues; use performance insights to prioritize improvement and resources.
• Drive continuous improvement using structured problem-solving and operational-excellence approaches; identify opportunities in QMS digitization, SOP standardization, training, and process redesign.
• Facilitate sharing of lessons learned and good practices across markets, locations, and functions, and support QMS digitization and automation with Quality.
• Build relationships across GSC, Supply Quality Operations, Regulatory Affairs, Procurement, Digital, and other functions; influence senior stakeholders and facilitate resolution of cross-functional issues.
• Represent Global Supply Chain and Global Logistics in relevant projects and transformation programs.
• Demonstrate visible leadership and accountability, promote prompt identification and escalation of QMS issues, provide direction during complex or high-risk events, and coach colleagues on QMS expectations and risk-based decisions.
• Build organizational capability through training, knowledge sharing, and development of QMS practitioners; where applicable, lead and develop logistics professionals through objective setting, coaching, and talent development.
• Ensure GDP/GxP onboarding, training, and development programs are deployed in alignment with GSC global and NexGen Academy programs.
• Review and optimize resource and capability deployment to meet internal and external customer needs and emerging business needs.
• Execute talent management and development programs that promote diversity, equity, and inclusion, and encourage growth gigs and zig-zag moves across GSC and PGS.

Benefits

• 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.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 22.5% of base salary.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior