GSC Quality Management System Lead

• Pfizer QMS Strategy and deployment within GSC & GL Develops, deploys and maintains the GSC QMS strategy and implementation roadmap. Ensure that GSC QMS requirements are clearly defined, effectively deployed and consistently applied across all GSC operations as appropriate including but not limited to:
• Owning the Warehousing & Distribution (W&D) Global Policy (GPOL) in alignment with the GLRC lead and GSC Risk and Compliance Policy

• Ensuring the development, deployment, adoption and lifecycle management / continuous improvement of W&D Global Standard Operating Procedures (GSOPs), Global Work Instructions (GWIs), Business Guidance documents (BGDs) and Global Forms (GFRMs) in full compliance with corporate quality requirements and regulatory expectations

• Ensuring the deployment and adoption of all non-W&D elements of Pfizer’s QMS by GSC operations.

• Ensuring the learning needs of all GSC colleagues are assessed and translated into training curricula

• Ensuring all colleagues in GSC complete all assigned compliance training, leveraging the NexGen Academy

• Ensuring corporate quality requirements and regulatory expectations in Pfizer’s QMS are translated to logistics vendors via the Quality and Technical Agreement.

• Establishing governance forums to track the development, deployment, adoption, lifecycle management / continuous improvement of the QMS.

• Periodically assess the effectiveness and maturity of the QMS and identify opportunities for standardization, simplification and improvement.

• QMS Compliance and Oversight within GSC & GL
• Provide oversight of compliance with applicable Good Distribution Practices, license requirements, corporate quality standards and relevant local regulations.

• Maintain effective quality oversight of warehousing and distribution as it relates to GSC operations.

• Monitors emerging or changing Quality and GDP regulatory expectations that may affect Logistics operations and coordinate the required QMS updates.

• Ensure that logistics operations remain inspection-ready and that required quality records are accurate, complete, controlled and readily retrievable.

• Support regulatory inspections, internal audits (inc. RQA audits of Vendors and Pfizer Country Offices (PCOs)) and corporate quality reviews as required in conjunction with the GLRC lead

• Coordinate responses to GSC-related observations and ensure that QMS remediation commitments are appropriately managed.

• QMS Deployment and Operations Compliance for GSC & GL
• Accountable to lead team of Market Compliance SMEs aligned to the markets at Anchor and Cluster level, working in close partnership with the ‘in market’ Logistics operations leads and reporting globally

• Leads local adoption of Revolution GSOPs/ GWIs/ BGDs at market / operations level, ensuring milestones are delivered, requirements adopted and regular auditing and process confirmation of same

• Market Compliance assess the development/ requirements and deployment of new or revised GSC QMS requirements across all operational teams, partnering with local process owners and operational leaders to translate requirements into sustainable working practices.

• Provide guidance, training and coaching on QMS expectations, quality risk management and QMS compliance responsibilities.

• Quality Risk Management and Escalation for GSC & GL
• Establish and maintain a consistent approach to identifying, assessing, mitigating and monitoring quality risks in alignment with GLRC lead

• Evaluate risks associated with GSC processes, distribution lanes, service providers, facilities, systems and operational changes.

• Ensure that appropriate QMS risk controls, owners, actions and review mechanisms are established, escalate unresolved QMS risks through established enterprise risk governance processes and GSC risk and compliance VM/ CI review

• Provide clear, evidence-based recommendations to support risk-based business decisions, track agreed mitigation plans through to sustainable closure.

• Quality Systems and Process Oversight for GSC & GL Provide governance and subject-matter leadership for GSC & GL related QMS processes, including but not limited to:
• Quality Management Review (QMR)

• Vendor Management

• Quality and Technical Agreements (QTA) (with respect to Logistics 3rd Parties/ Partners)

• Internal Audits & Inspection Readiness

• Quality Risk Management (QRM)

• Non-conformance management / deviations

• Corrective and Preventive Actions (CAPA)

• Change Control (CC)

• Document and records management

• Training compliance

• Logistics Service Provider Quality Management
• Ensure the quality governance framework for logistics service providers and other relevant vendors, with clearly defined Quality expectations, responsibilities, escalation pathways and performance-review arrangements

• Partner with GLRC Lead, Quality, Operational and Procurement teams to ensure that Logistics Quality and Technical requirements are appropriately incorporated into provider selection, onboarding and ongoing governance.

• Monitor provider quality performance, recurring events, audit outcomes, QMS remediation plans and systemic and emerging risks

• Performance Management and Management Review
• As part of GSC Risk and Compliance framework, maintain Logistics QMS effectiveness and quality-system performance indicators

• Monitor trends, Identify systemic issues, recurring events and areas of increasing compliance risk

• Track action closure, QMS remediation effectiveness and overall QMS health leveraging Risk Register process for major systemic trends/ issues

• Use performance insights to prioritize improvement activities and resource requirements.

• Continuous Improvement
• Drive continuous improvement of the GSC & GL QMS using structured problem-solving and operational-excellence approaches

• Identify opportunities to simplify, standardize and strengthen Logistics QMS processes without compromising compliance including but not limited to:

• QMS digitization

• SOP standardization

• Training programs

• QMS process redesign

• Facilitate cross-market / cross-location / cross-functional sharing of lessons learned and good practices.

• Support digitization and automation of QMS processes in collaboration with Quality where appropriate

• Cross-Functional Leadership
• Build strong working relationships across Global Supply Chain, Supply Quality Operations (SOQ), Regulatory Affairs, Procurement, Digital and other relevant functions

• Influence senior stakeholders on GSC & GL QMS priorities, risk acceptance, QMS remediation requirements and resource needs

• Facilitate resolution of cross-functional quality and compliance issues while maintaining clear accountability

• Represent Global Supply Chain / Global Logistics in relevant projects and transformation programs

• Leadership Ecosystem The GSC Quality Management System Lead is expected to:
• Demonstrate visible leadership and personal accountability for QMS quality and compliance.

• Promote a culture in which QMS issues are identified, discussed and escalated promptly.

• Influence stakeholders without relying solely on formal authority.

• Provide clear direction during complex or high-risk quality events.

• Coach colleagues and leaders on quality-management-system expectations and risk-based decision-making.

• Encourage collaboration, transparency, continuous learning and disciplined execution.

• Build organisational capability through training, knowledge sharing and development of QMS practitioners.

• Where applicable, lead and develop a team of logistics professionals through effective objective setting, coaching and talent development.

• Organization, Training and Development Accountable to ensure GDP / GxP comprehensive onboarding, training and development programs are deployed in alignment with the GSC global programs and NexGen Academy programs. Reviews and optimises deployment of resources and capabilities effectively and efficiently across the organisation to meet the needs of our internal and external customers, and emerging needs of the business. Orchestrates and executes robust talent management and development programs across their organization, in a manner that promotes diversity, equity and inclusion. Promote and encourage growth gigs and zig zag moves in partnership with peers and colleagues across GSC and PGS.

• Applicant must have a bachelor's degree with at least 12 years of

• Applicant must have a bachelor's degree with at least 12 years of

• 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 BoH 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.

• 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 of LSP/ 3rd Party oversight an advantage

• 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 / in-house DC operations

• Experience operating in a regional or global matrix organisation

• Global/ regional project management experience and certification preferred

• Ability to work flexible hour