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 SME for the LIR process across PharmSci.

Audit & Inspection Support

• Partner with stakeholders to maintain inspection readiness and promote a culture of quality and continuous improvement.

• Serve asthe primary Process SME during internal audits, and regulatory inspections.

• Explain process design, governance, and compliance rationale to auditors and inspectors.

• Share audit and inspection learnings with the Global Process Owner, fellow LPOs, and Inspection Readiness teams to support continuous improvement.

• Co-develop responses and remediation plans for process-specific audit and inspection observations.

QUALIFICATIONS

Must-Have

• Applicant must have a bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience.

• Exceptional organizational and project management skills.

• Strong knowledge of laboratory investigations/OOS management, quality systems, and GMP/GDP requirements.

• Demonstrated experience leading process deployments, governance activities, or quality system improvements.

• Ability to influence stakeholders across all functions and levels of the organization.

• Strong analytical, problem-solving, and continuous improvement mindset.

• Experience working in regulated pharmaceutical, biotechnology, or quality environments.

• Excellent communication, collaboration, and change management skills.

• Proactive approach to problem-solving.

• Proficiency in taking decisive action based on quality and compliance metrics and trends.

Nice-to-Have

• Strong Knowledge of Nonconformance.

• Experience developing training materials or delivering training or driving organizational capability building.

• Skilled in negotiation, and conflict resolution.

• Experience with external Laboratory LIR.

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, includingrisk management and ethical use.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

As this is a global role there may be limited times when working outside of standard working hours is required.

OTHER JOB DETAILS

• Last Date to Apply for Job: August 13, 2026

• Additional Location Information: Europe - Any Pfizer Site, United Kingdom – Sandwich, USA - Any Pfizer Site, MA – Andover, MO - St. Louis

• Eligible for Relocation Package – NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

• Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control