Centralized Document Management Team (CDMT) Specialist

Why Patients Need You

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.

What You Will Achieve

This role is part of the Centralized Document Management Team (CDMT) responsible for end-to-end lifecycle management of GMP documents using QualityDocs replacing legacy PDOCs processes. The CDMT serves as a centralized cross-functional capability supporting the entire site including API Drug Product Engineering Maintenance and Utilities (EMU) and Quality Operations (QO) 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.

This position resides in a team environment within the Centralized Document Management Team and regularly interfaces with colleagues across the Kalamazoo Site 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.

How You Will Achieve It

• Document Lifecycle Management (QualityDocs)

  • Author review and manage SOPs Master Batch Records Non-Master Records and other GMP documents directly within QualityDocs ensuring consistent application of templates taxonomy and metadata standards.

  • Intake change requests draft documents facilitate stakeholder alignment and drive timely approvals through quality systems.

  • Perform controlled print and reconciliation activities in accordance with GMP documentation requirements ensuring issued copies are accurate accounted for reconciled and retained as required.

• Change Control & Compliance

  • Serve as responsible reviewer/approver for document changes within GMP frameworks; provide change control guidance to originators.

  • Ensure compliance with cGMP ALCOA data integrity principles and site procedures across all documentation activities.

• Centralized Intake Prioritization & Delivery

  • 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).

  • Monitor workflows manage queues track due dates escalate off-track work and provide stakeholder visibility on workload and timelines.

• Standardization Harmonization & Document Strategy

  • Drive harmonization across functional areas reducing duplication and variation; apply standard templates language and structure; support write-once reuse principles.

  • Support site Document Governance forums with data insights and recommendations for simplification reduction and lifecycle optimization.

• Migration & Transformation

  • Execute and support migration activities from PDOCs/legacy systems into QualityDocs ensuring accuracy completeness and compliance during each migration wave.

  • Partner with CDMT leadership on resource planning and execution.

• Inspection Readiness & Audit Support

  • Ensure documents are inspection-ready and traceable; act as SME during audits/inspections for document management processes; support related CAPA and audit actions.

• Continuous Improvement Metrics & Training

  • Track and trend documentation metrics (error categories cycle times throughput) and identify improvement opportunities.

  • Develop OJTs SOPs and job aids; train and mentor team members and stakeholders on documentation processes and QualityDocs.

Qualifications

Must-Have

• Bachelors degree with any years of experience or an Associates degree with 4 years of relevant experience or a high school diploma (or equivalent) and 6 years of relevant experience

• Working knowledge of Quality Assurance/Quality Control systems and Good Manufacturing Practices (cGMP).

• Demonstrated proficiency in applicable computer software and electronic document management systems.

• Effective verbal and written communication skills and ability to interact across all organizational levels.

• Self-motivated with demonstrated personal accountability flexibility and willingness to learn new and changing responsibilities.

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Nice-to-Have

• Experience with electronic document management systems such as QualityDocs QTS and/or PDOCs.

• Subject matter expertise in GMP documentation (SOPs batch records change control processes).

• Knowledge of Record Retention requirements and familiarity with site SOPs.

• Knowledge of API and/or Drug Product master record systems (QPSNT and/or MBR).

• Experience in document standardization harmonization system implementation or migration projects.

• Strong analytical critical thinking and attention-to-detail skills.

• High proficiency in Word Visio Excel and Outlook.

• Demonstrated ability to work both independently and collaboratively in a cross-functional team environment.

• Demonstrated commitment to Pfizer Values (Customer Focus Courage Excellence Equity Joy).

• Demonstrated ability to learn and master new applications software

• Experience in conducting and documenting manufacturing incident or customer complaint investigations

• Knowledge of regulatory requirements and quality standards in the pharmaceutical industry

• Strong problem-solving skills and the ability to think critically

• Ability to work independently and as part of a team

• Excellent written and verbal communication skills

• Proficiency in data analysis and reporting

• Strong interpersonal skills and the ability to build effective working relationships

• Adaptability and flexibility in a fast-paced environment

• 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

PHYSICAL/MENTAL REQUIREMENTS

• Office-based position with periodic time in the production environment.

• Extended periods of sitting and computer use.

• Occasional lifting of up to 25 lbs.

• Aseptic gowning training may be required for production-area work.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• On-premise work assignment at the Kalamazoo site.

• Occasional weekend or evening work may be required to support a 24/7 manufacturing operation audits/inspections or QualityDocs migration deployment activities.

Other Job Details:

• Work Location Assignment:On Premise

• Last day to apply: August 14th

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 onPfizer Careers.