Sr. Manager, Quality Systems Governance & Analytics

About this role

What You Will Achieve The Sr. Manager, Quality Systems & Analytics reports to the Director Compliance and provides leadership, strategic direction, and technical oversight for the Quality Systems & Analytics organization at the McPherson site. The role is accountable for ensuring effective execution, governance, and continuous improvement of several Quality Systems such quality data and analytics, medical device and combination product (MDCP) quality support, validation support, CAPA process and project execution activities.

This leader ensures quality systems are inspection-ready, compliant with applicable Pfizer Quality Standards, current Good Manufacturing Practice (cGMP) expectations, and applicable device/combination product requirements. The role partners across Quality, Manufacturing, Engineering, Automation, Validation, Laboratory, Regulatory Affairs, Business Technology, and other stakeholders to drive data-informed decisions, robust compliance outcomes, colleague development, and reliable execution of site priorities.

In this role, you will: • Provide technical and functional leadership to the Quality Systems & Analytics team, including salaried individual contributors supporting training, learning systems, validation support, quality data, MDCP quality, CAPA coordination, and project execution. • Establish priorities, governance, and performance expectations for quality systems activities to ensure reliable execution, risk-based decision-making, audit readiness, and alignment with site and Pfizer Quality objectives. • Oversee site training strategy and execution, including learning process governance, PLS administration, training effectiveness, assignment accuracy, completion metrics, and escalation of training risks impacting compliance or operations. • Oversee MDCP quality support activities, including quality review/approval of lifecycle documentation, design control/risk management support, complaint or non-conformance support, supplier or quality agreement inputs, and applicable device/combination product requirements. • Direct validation support quality activities and ensure timely, compliant review and approval of validation protocols, reports, deviations, change controls, qualification packages, and related GMP documentation. • Lead quality data and analytics capabilities, including KPI governance, data integrity, dashboard/reporting routines, trend analysis, metric accuracy, and translation of data insights into preventive actions and continuous improvement opportunities. • Provide oversight of CAPA coordination and project specialist activities, ensuring effective prioritization, milestone management, stakeholder alignment, closure discipline, and escalation of risks to compliance, supply, or inspection readiness. • Partner cross-functionally with Manufacturing, Engineering, Automation, Laboratory, Validation, Regulatory Affairs, Business Technology, and Quality leadership to resolve complex issues, support regulatory and third-party inspections, and implement sustainable process improvements. • Coach, mentor, and develop colleagues; foster a culture of accountability, collaboration, continuous improvement, and quality ownership across the team and broader site network. • Manages and leads people, technological and financial resources at the Sub Business Unit/Sub Operating Unit level for multiple projects and on-going work activities of moderate complexity within multiple sub functions; May lead by influence rather than direct authority • Solves complex problems across own and related disciplines; Decisions impact Quality Unit midterm objectives while long-term decisions are reviewed by senior management • Manage teams that execute direction in support of Sub Business Unit/Sub Operating Unit leadership objectives • Provides input to senior management decisions that have impact on business direction within Sub Business Unit/Sub Operating Unit • Provides significant peer leadership to colleagues throughout the site to develop responses to regulatory requests.

Here Is What You Need (Minimum Requirements) • Applicant must have a Bachelor's degree with at least 6+ years of experience; OR a Master's degree with at least 5+ years of experience; OR a PhD with 1+ years of experience • Experience in Quality, Compliance, Quality Systems, Validation, Training/Learning, Medical Device/Combination Product quality, analytics, or related GMP-regulated operations. • Supervisory, people leadership, or matrix leadership experience within a regulated manufacturing, quality, or technical environment. • Demonstrated ability to interpret complex quality system data, make risk-based decisions, manage priorities, and communicate effectively with leadership and cross-functional stakeholders. • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

  Bonus Points If You Have (Preferred Requirements) • 3+ years of relevant experience, particularly in quality, compliance, quality systems, or regulated manufacturing roles • Strong understanding of cGMP expectations and ability to support regulatory inspections, audits, investigations, CAPA, and quality system governance. • Project management experience • Experience with training system governance, PLS/LMS administration, qualification curricula, and training effectiveness metrics. • Experience with validation lifecycle support, GMP documentation review/approval, and risk-based validation principles. • Experience with MDCP/device quality requirements, including design controls, risk management, ISO 13485, ISO 14971, 21 CFR 820, or drug-device combination product requirements. • Experience developing and maintaining quality metrics, dashboards, data integrity controls, and trend analysis routines. • Project management, cont

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