PharmSci Local Process Owner (LPO) – Laboratory Investigation Report (LIR) (Secondment - 12 Months)

WHY PATIENTS NEED YOU

At Pfizer, our ability to deliver breakthroughs to patients depends on the strength, reliability, and continuous improvement of our global business processes and Quality Management Systems. As a Local Process Owner within Pharmaceutical Sciences (PharmSci), you will provide strategic leadership and governance for critical end-to-end processes, ensuring they remain compliant, efficient, and fit for purpose. Through effective governance, risk management, capability building, and data-driven decision-making, you will help ensure Pfizer continues to deliver medicines safely, reliably, and efficiently to patients worldwide.

WHAT YOU WILL ACHIEVE

As part of the Non-Conformance Strategic Compliance Team within PSOQ, the Local Process Owner (LPO) serves as the Pharmaceutical Sciences (PharmSci) business owner for the Laboratory Out Of Specification (OOS)/Questionable Result (QR) process. The role is responsible for ensuring the effective design, deployment, governance, compliance, performance monitoring, and continuous improvement of the Investigational Product (IP) LIR process, while serving as the primary liaison between PharmSci and the Global Process Owner (GPO).

The successful candidate will drive process excellence, support regulatory compliance and inspection readiness, influence global process strategy, and champion simplification and adoption across the organization.

HOW YOU WILL ACHIEVE IT

Process Ownership & Governance

• Own the PharmSci Investigational Product LIR process and ensure ongoing compliance with global procedures, regulatory requirements, and Pfizer expectations.

• Define and continuously improve the PharmSci LIR process in collaboration with SMEs and the Global Process Owner.

• Establish and maintain the appropriate process documentation structure, including Global Work Instructions (GWIs), Local Work Instructions (LWIs), and supporting materials.

• Lead local process governance activities and communities of practice.

• Represent PharmSci in Global Process-Centric Teams.

• Monitor process health, performance metrics, compliance trends, and key performance indicators (KPIs).

• Identify and address emerging risks, adverse trends, compliance gaps, and improvement opportunities.

• Escalate process risks, compliance concerns, and significant issues to the Global Process Owner, PharmSci Revolution Site Lead and appropriate PharmSci leadership.

• May serve as backup LPO for other Quality Management System (QMS) processes.

Global Process Deployment & Change Management

• Lead the implementation and deployment of Global LIR process enhancements and system changes within PharmSci.

• Manage local change management activities, including impact assessments, local change controls, implementation actions, and stakeholder engagement.

• Ensure all deployment deliverables, documentation updates, training needs analyses, and readiness activities are completed on schedule.

Training Development & Tracking

• Develop and maintain IP LIR learning materials, and supporting resources.

• Identify colleagues requiring LIR training and partner with training teams to ensure appropriate assignment, completion, and qualification.

Digital Enablement & Continuous Improvement

• Identify opportunities to simplify, standardize, and digitize process execution and documentation.

• Define digital system requirements in collaboration with SMEs to enhance user experience, compliance, and process effectiveness.

• Represent PharmSci in digital enhancement discussions and process transformation initiatives.

• Lead or contribute to Continuous Improvement (CI) projects that strengthen the global LIR process and user experience.

• Champion process simplification, standardization, and adoption across the organization.

Stakeholder Engagement & Collaboration

• Build strong partnerships with local SMEs, Quality colleagues, business partners, and global process stakeholders.

• Gather and represent local business needs, regulatory commitments, and best practices in discussions with the Global Process Owner.

• Influence global process design by advocating for PharmSci requirements where appropriate.

• Foster alignment across functions and ensure effective communication of process changes and expectations.

• Support knowledge sharing and build organizational capability by communicating process expectations, design decisions, and best practices.

• Act as a trusted advisor and SM