Centralized Document Management Team (CDMT) Specialist

<p><span><b>Why Patients Need You</b> </span></p><p>Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will have a direct impact on patient care. Your focus and commitment will be essential in achieving project tasks and goals, fostering a collaborative environment for your colleagues. Your hard work and dedication will help Pfizer reach new milestones and make a significant impact on patients worldwide.</p><p></p><p></p><p><span><b>What You Will Achieve</b></span></p><p>This role is part of the <b>Centralized Document Management Team (CDMT)</b> responsible for end-to-end lifecycle management of GMP documents using <b>QualityDocs</b>, replacing legacy PDOCs processes. The CDMT serves as a centralized, cross-functional capability supporting the entire site including <b>API, Drug Product, Engineering, Maintenance and Utilities (EMU), and Quality Operations (QO)</b> at the Kalamazoo site. The incumbent ensures standardized document creation, governance, migration, and continuous improvement aligned with cGMP, data integrity, and Pfizer Human Performance standards. The role shifts documentation from transactional processing to a strategic, standardized, and data-driven capability supporting inspection readiness and operational efficiency.</p><p>This position resides in a team environment within the Centralized Document Management Team and regularly interfaces with colleagues across <b>the Kalamazoo Site</b>, including Document Governance, Quality Systems, GMP Training, Compliance, Operations, Engineering, and site leadership. The role also supports interactions with internal audit teams and external regulatory authorities during inspections.</p><p></p><p></p><p><span><b>How You Will Achieve It</b></span></p><ul><li><p><span><b>Document Lifecycle Management (QualityDocs)</b></span></p><ul><li><p><span>Author, review, and manage SOPs, Master Batch Records, Non-Master Records, and other GMP documents directly within <b>QualityDocs</b>, ensuring consistent application of templates, taxonomy, and metadata standards.</span></p></li><li><p><span>Intake change requests, draft documents, facilitate stakeholder alignment, and drive timely approvals through quality systems.</span></p></li><li><p><span>Perform controlled print and reconciliation activities in accordance with GMP documentation requirements, ensuring issued copies are accurate, accounted for, reconciled, and retained as required.</span></p></li></ul></li><li><p><span><b>Change Control &amp; Compliance</b></span></p><ul><li><p><span>Serve as responsible reviewer/approver for document changes within GMP frameworks; provide change control guidance to originators.</span></p></li><li><p><span>Ensure compliance with cGMP, ALCOA data integrity principles, and site procedures across all documentation activities.</span></p></li></ul></li><li><p><span><b>Centralized Intake, Prioritization &amp; Delivery</b></span></p><ul><li><p><span>Operate within the centralized intake model, triaging and prioritizing work across API, DP, EMU, QO and the rest of the site using standardized criteria (inspection readiness, supply impact, compliance risk).</span></p></li><li><p><span>Monitor workflows, manage queues, track due dates, escalate off-track work, and provide stakeholder visibility on workload and timelines.</span></p></li></ul></li><li><p><span><b>Standardization, Harmonization &amp; Document Strategy</b></span></p><ul><li><p><span>Drive harmonization across functional areas — reducing duplication and variation; apply standard templates, language, and structure; support "write-once, reuse" principles.</span></p></li><li><p><span>Support site Document Governance forums with data, insights, and recommendations for simplification, reduction, and lifecycle optimization.</span></p></li></ul></li><li><p><span><b>Migration &amp; Transformation</b></span></p><ul><li><p><span>Execute and support migration activities from PDOCs/legacy systems into QualityDocs, ensuring accuracy, completeness, and compliance during each migration wave.</span></p></li><li><p><span>Partner with CDMT leadership on resource planning and execution.</span></p></li></ul></li><li><p><span><b>Inspection Readiness &amp; Audit Support</b></span></p><ul><li><p><span>Ensure documents are inspection-ready and traceable; act as SME during audits/inspections for document management processes; support related CAPA and audit actions.</span></p></li></ul></li><li><p><span><b>Continuous Improvement, Metrics &amp; Training</b></span></p><ul><li><p><span>Track and trend documentation metrics (error categories, cycle times, throughput) and identify improvement opportunities.</span></p></li><li><p><span>D