PharmSci Local Process Owner – Laboratory Investigation Report

Pfizer

Local Process Owner leading the LIR process within Pharmaceutical Sciences at Pfizer. Ensuring compliance, process governance, and continuous improvement for global medicines delivery.

Posted 7/31/2026full-timeGroton • Connecticut, Massachusetts • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing the PharmSci Investigational Product LIR process, ensuring compliance with global regulatory requirements and quality systems. Proven ability to lead process improvements, stakeholder engagement, and training initiatives within regulated pharmaceutical environments.

Highest-signal resume keywords

Process GovernanceQuality Management Systems (QMS)GMP/GDP RequirementsContinuous Improvement (CI)Stakeholder Engagement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Laboratory InvestigationsOOS ManagementProcess DeploymentChange ManagementPerformance Metrics Monitoring

Soft Skills

Organizational SkillsProject ManagementAnalytical Problem-SolvingCommunicationCollaboration

Industry Keywords

PharmaceuticalBiotechnologyRegulatory ComplianceProcess DocumentationTraining Development

About the role

Key responsibilities & impact

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.
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.
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.
Identify opportunities to simplify, standardize, and digitize process execution and documentation.
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.
Build strong partnerships with local SMEs, Quality colleagues, business partners, and global process stakeholders.
Partner with stakeholders to maintain inspection readiness and promote a culture of quality and continuous improvement.

Requirements

What you’ll need

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 an 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.

Benefits

Comp & perks

Professional growth opportunity
Flexible work schedule