Manager, Process Performance Qualification

About the role

The role serves as the functional expert for assigned validation programs, providing technical guidance, oversight, and coaching to direct reports and cross-functional partners to ensure compliant and effective execution of validation lifecycle activities.

Responsibilities

• Lead, develop, and mentor a team of validation engineers responsible for Process Qualification, Cleaning Validation, and Continued Process Verification (CPV) activities supporting sterile injectable manufacturing operations.
• Serve as the technical and functional expert for validation programs by providing guidance, oversight, and coaching to direct reports and cross-functional teams while building expertise across related disciplines.
• Lead and manage people, technology, and financial resources for multiple validation projects and ongoing work activities of moderate complexity involving Operations, Quality, Engineering, Technical Services, and Project Management stakeholders.
• Establish and maintain Validation Master Plans and validation lifecycle strategies that ensure compliance with regulatory requirements, Pfizer Quality Standards, and business objectives.
• Identify opportunities for process, product, and validation program improvements and drive implementation of innovative, science-based, risk-based solutions that improve compliance, efficiency, and operational performance.
• Solve moderately complex technical and operational challenges within validation programs and partner across functions to address issues impacting manufacturing, quality, and compliance objectives.
• Provide technical leadership for investigations, deviations, CAPAs, change controls, and risk assessments to ensure robust lifecycle management of validated processes and cleaning programs.
• Support regulatory inspections, customer audits, and internal assessments by representing validation programs and maintaining a state of continuous inspection readiness.
• Influence stakeholders, facilitate effective decision-making, and communicate complex technical concepts while building alignment across cross-functional teams.
• Actively share knowledge across departments, contribute to knowledge management initiatives, and strengthen technical capabilities within the organization.
• Audit talent needs, develop colleagues through coaching and mentoring, and ensure training and development programs support current and future business requirements.
• Monitor validation performance metrics, prioritize resources, and continuously improve operational effectiveness while maintaining quality and compliance standards.

Qualifications

• Bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR associate's degree with 8 years of experience; OR high school diploma (or equivalent) and 10 years of relevant experience.