GSC Quality Management System Lead

ROLE SUMMARY

The GSC Quality Management System (QMS) Lead is accountable for the operational deployment, lifecycle management / continuous improvement of the Pfizer Quality Management System for Global Supply Chain (GSC) & specifically Global Logistics.

The role ensures that GSC activities are performed in accordance with applicable regulatory requirements, Good Distribution Practices, corporate quality standards and approved policies, procedures, work instructions and forms.

The position provides leadership for Logistics Vendor Management, Quality Risk Management, Inspection Readiness, QMS performance and remediation, and serves as a primary escalation point for significant GSC quality management system compliance issues and risks.

Working across Global Logistics, Quality Operations, Regulatory and other partner functions, the role embeds quality into operational decision-making and promotes a culture focused on product quality, patient safety, quality and compliance to ensure reliable supply. They will develop and sustain an effective team through effective recruitment, onboarding and training as well as ensuring the development and growth of colleagues to achieve their full potential.

Non QMS processes, Compliance, Enterprise Risk strategy and GSC Risk Register are owned by the GLRC Lead, as well as overall performance management, VM and CI processes. The GSC QMS Lead will partner closely with the GLRC lead to ensure an integrated risk management program, integrated audit program and risk assessment/ prioritisation of the local and global logistics operations.

The incumbent will report to the VP Global Logistics and will be a member of the GL Leadership Team. They will also support and partner with the LT to drive the T4 Blueprint, sponsor selected initiatives and be a full member of the T4 Leadership ecosystem.

ROLE RESPONSIBILITIES

• •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-mar