- Company Name
- OMERIN Group
- Job Title
- CHEF DE PROJET IT TRANSVERSE - BU MEDICALE (H/F)
- Job Description
-
Job Title: IT Project Manager – Medical Business Unit
Role Summary:
Lead the planning, execution, and validation of application deployments (ERP, MES, LIMS, PLM, CRM) within a regulated medical manufacturing environment. Conduct gap analyses, audit existing solutions, and design compliant deployment strategies while balancing regulatory mandates and operational efficiency.
Expectations:
- Deliver projects on scope, schedule, and budget while meeting ISO 13485, CFR 21 Part 11, GAMP 5, and CSV requirements.
- Champion continuous improvement, stakeholder alignment, and effective change adoption across business and IT teams.
Key Responsibilities:
- Audit legacy projects and current application landscapes; assess effectiveness and regulatory compliance.
- Define project scope, objectives, and deliverables in collaboration with business, quality, and regulatory stakeholders.
- Develop detailed project plans, allocate resources, and coordinate cross‑functional teams (IT, operations, quality, regulators, external vendors).
- Identify, monitor, and mitigate technical, organizational, and regulatory risks.
- Oversee system integration, configuration, customization, testing, and go‑live activities for ERP, MES, LIMS, PLM, CRM, and related applications.
- Lead validation activities (IQ, OQ, PQ), ensuring documentation meets CSV/GxP standards without excessive bureaucracy.
- Facilitate user training, post‑deployment support, and drive adoption of new tools.
Required Skills:
- Project Management (Agile/Scrum, Waterfall, ITIL, Lean).
- In‑depth knowledge of regulated medical manufacturing standards (ISO 13485, 21 CFR Part 11, GAMP 5, CSV).
- Hands‑on experience with ERP, MES, LIMS, PLM, or WMS implementations.
- Strong stakeholder communication, negotiation, and influence abilities.
- Risk assessment, dependency tracking, and priority adjustment in a dynamic environment.
- Familiarity with IT integration concepts (middleware, APIs, ETL, system interoperability).
- Cyber‑security awareness: access control, audits, and compliance documentation.
Required Education & Certifications:
- Bachelor’s or Master’s degree in Computer Science, Information Systems, Industrial Engineering, Bioinformatics, or related field (minimum 4–5 years of higher education).
- Project Management certifications (PMP, PRINCE2, or equivalent) preferred; Agile ScrumMaster, ITIL Foundation, or GAMP 5 validation training are advantageous.