Data Integrity Project Manager
Overview
We are seeking an experienced Data Integrity Project Manager to lead the deployment and implementation of a large-scale data integrity programme across multiple pharmaceutical manufacturing sites. The successful candidate will act as the primary interface between manufacturing sites, system vendors, engineering partners, and project stakeholders, ensuring consistent delivery against project timelines, quality requirements, and regulatory expectations.
This is a highly visible role requiring strong project management, stakeholder engagement, and pharmaceutical compliance experience.
Key Responsibilities
- Serve as the central communication point between manufacturing sites, system vendors, engineering partners, and project stakeholders.
- Manage overall project delivery, timelines, milestones, risks, and dependencies across multiple sites.
- Coordinate site readiness activities, workshops, and preliminary meetings to support project execution.
- Develop, maintain, and communicate detailed project plans, milestone trackers, and resource forecasts.
- Provide regular project reporting, KPI updates, and escalation of issues or deviations to senior stakeholders.
- Coordinate qualification and validation activities with site teams to ensure compliance with GMP and Data Integrity requirements.
- Manage the coordination of quotations, purchase orders, software licenses, hardware procurement, and associated project documentation.
- Ensure alignment with GxP, Data Integrity, CSV, and regulatory requirements throughout the project lifecycle.
- Facilitate collaboration between Quality, IT, Engineering, Operations, Automation, and Validation teams.
- Drive project governance, change control, risk management, and issue resolution activities.
- Support implementation, rollout, and adoption activities across manufacturing sites.
- Track project budgets, schedules, and deliverables to ensure successful execution through programme completion.
Requirements
- 5+ years' project management experience within pharmaceutical, biotech, or life sciences environments.
- Demonstrated experience delivering Data Integrity, CSV, Digitalisation, MES, Automation, or Quality Compliance projects.
- Strong understanding of GMP, GxP, Annex 11, 21 CFR Part 11, and Data Integrity principles.
- Experience coordinating cross-functional teams across multiple stakeholder groups and locations.
- Proven ability to manage project plans, budgets, schedules, risks, and reporting deliverables.
- Experience working with Quality, Manufacturing, IT, Engineering, Automation, and Validation functions.
- Excellent communication and stakeholder management skills.
- PMP, Prince2, or equivalent project management certification preferred.
Preferred Experience
- Pharmaceutical manufacturing site experience.
- Data Integrity remediation or continuous improvement programmes.
- Computer System Validation (CSV) projects.
- MES, SCADA, Automation, PLC, Historian, or electronic batch record systems.
- Multi-site deployment programmes.
Contract Details
- Immediate start preferred.
- Contract position running through December 2027.
- Long-term programme supporting strategic Data Integrity initiatives across multiple manufacturing sites.
- Competitive contract rate available.
FAQs
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