It project manager quality systems/ pharma F/H
Core
Managing and updating IT systems supporting Quality business processes in compliance with pharmaceutical regulations.
Role type
IT Project Manager (Quality Systems)
Builds
Quality management systems (QMS) and related IT infrastructure
Domain
Pharmaceutical industry / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
IT project management, pharmaceutical industry knowledge, GxP regulations, quality processes, English language, financial analysis, change management, system administration, incident resolution, stakeholder management, business case development, technology scouting
Preferred skills
ITIL, PMBOK, GDPR, GAMP 5, 21 CFR Part 11
Technologies
Ennov Doc, Ennov Training, Ennov Dossier, Avanteam QMS
Responsibilities
Maintain operational excellence for assigned systems, resolve incidents, configure new features, manage user and vendor relationships, manage system updates, administer system access, support users, develop business cases with ROI analysis, follow SI validation activities, supervise continuous improvement, pilot system evolution, manage deployment and upgrade projects, select project participants, create project plans, meet with stakeholders, conduct technology scouting
Seniority
Mid-Senior, hands-on IC