Data Steward PM

Data Steward Project Manager / Data Integrity Specialist (Remediation Focus)

Contract: 6-month contract

Pay Rate: ~$45-46/hour





Position Summary

The Data Steward Project Manager / Specialist will support the Site Data Steward in executing a structured remediation program addressing identified data integrity (DI) gaps across Quality and Operations systems, equipment, and processes.

This role is highly execution-focused and project-driven. Following a completed enterprise gap assessment, the organization is managing a large portfolio of remediation initiatives-each system, piece of equipment, or procedure functioning as its own mini-project. The Data Integrity Project Manager will provide hands-on project management, coordination, and tracking to ensure remediation efforts are completed on time, consistently, and in alignment with regulatory expectations.

Business Context





• A formal Data Integrity remediation program is underway following a comprehensive gap assessment completed last year.
• The assessment evaluated compliance against:
• Data Integrity (DI) standards
• Computer System Validation (CSV)
• Audit trails
• User access controls
• 21 CFR Part 11 requirements
• Periodic system review expectations
• Scope includes:
• Quality and Operations systems
• Laboratory equipment
• Automated production equipment
• The resulting output is a detailed list of remediation actions spanning procedures, equipment, and IT systems.
• This role exists to offload execution and coordination from the Data Steward, who owns technical oversight but is stretched across too many parallel initiatives.





Key Responsibilities

Data Integrity Remediation & Project Management





• Manage and drive multiple concurrent remediation projects resulting from completed DI gap assessments.
• Track timelines, dependencies, milestones, and deliverables across multiple workstreams.
• Maintain structured project plans, trackers, and dashboards to ensure visibility and accountability.
• Drive remediation activities to completion, escalating risks and delays as needed.





Remediation Scope Includes

Procedural Remediation





• Manage multiple change controls, each containing multiple procedural updates.
• Coordinate procedure revisions, approvals, training requirements, and implementation.
• Ensure alignment with shared procedures across multiple sites (including Phoenix).





Equipment Remediation





• Manage ~8 equipment-focused remediation projects.
• Coordinate activities related to equipment modification, replacement, qualification, and documentation updates.
• Support alignment with CSV and data integrity expectations for automated equipment.





IT / Computerized Systems





• Support remediation activities for Quality and Operations systems.
• Coordinate compliance updates related to audit trails, access controls, validation documentation, and periodic reviews.





Cross-Functional Coordination





• Partner closely with the Data Steward to align remediation priorities and execution plans.
• Coordinate with stakeholders across:
• Quality (QA, QC, Validation)
• Operations & Manufacturing
• IT / Automation
• Engineering
• Ensure remediation approaches remain consistent across sites and governing procedures.





Data Integrity & Compliance Support





• Apply working knowledge of:
• Data Integrity principles (ALCOA+)
• GMP environments
• CSV and computerized systems
• Change control processes
• Support data process mapping and risk-reduction initiatives.
• Ensure remediation activities meet regulatory, quality, and business requirements.





Tools & Systems





• MS Project (preferred but not required)
• Strong use of trackers, spreadsheets, timelines, and status reporting tools
• Familiarity with change control systems and quality documentation workflows





Ideal Candidate Profile





• Strong Project Manager first, with supporting experience in Quality, Compliance, CSV, or Validation.
• Comfortable managing many detailed workstreams in parallel.
• Highly organized, execution-oriented, and detail-driven.
• Able to "plow through" structured remediation tasks and close them efficiently.
• Confident communicator who can coordinate across functions and sites.
• Able to work independently with minimal supervision while maintaining strong stakeholder alignment.





Required Qualifications





• Bachelor's degree
• 4-6+ years of relevant experience
• Demonstrated project management experience in regulated environments
• Working knowledge of:
• Data Integrity principles
• GMP operations
• Change control processes
• Computerized systems and automation
• Strong communication and collaboration skills

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