- Company Name
- OMERIN Group
- Job Title
- CHEF DE PROJET IT TRANSVERSE - BU MEDICALE (H/F)
- Job Description
-
**Job Title:** IT Project Manager – Cross‑Business Unit (Medical)
**Role Summary:**
Lead and coordinate application projects (ERP, MES, QMS, LIMS, PLM, CRM) across the Medical Business Unit, ensuring operational effectiveness and regulatory compliance (ISO 13485, 21 CFR Part 11, GAMP 5, CSV). Act as a liaison between business stakeholders, IT teams, and regulatory authorities, driving project delivery from concept through validation and adoption.
**Expectations:**
- Deliver projects within scope, budget, and schedule, maintaining regulatory and quality standards.
- Influence business processes and technology solutions, balancing compliance with operational efficiency.
- Mentor teams and support change management initiatives.
- Provide clear communication to senior management and stakeholders on progress, risks, and mitigation actions.
**Key Responsibilities:**
- Conduct audit & analysis of existing applications; identify gaps versus objectives & regulatory requirements.
- Define project scope, objectives, priorities, and produce formal project charters.
- Plan, deploy, and monitor project timelines; coordinate internal & external resources.
- Manage risk, including technical, organizational, and regulatory aspects.
- Oversee system integration, customization, and testing (IQ/OQ/PQ).
- Confirm compliance through collaboration with Quality and Regulatory teams.
- Design and deliver targeted training; monitor post‑deployment performance and adjust tools as needed.
**Required Skills:**
- Project Management: Agile, Scrum, Waterfall, ITIL, Lean.
- Industrial Application Expertise: ERP, MES, LIMS, PLM, WMS.
- Regulatory & Validation: ISO 13485, 21 CFR Part 11, GAMP 5, CSV (IQ/OQ/PQ).
- IT Security & Compliance: Access management, audit, documentation.
- Technical Integration: Middleware, API, ETL, system interoperability.
- Strong analytical, communication, and leadership abilities; change‑management competence.
**Required Education & Certifications:**
- Minimum Bachelor’s/Master’s (Bac + 4/5) in Computer Science, Information Systems, Industrial Engineering, or Bioinformatics.
- Certifications in project management (PMP, Prince2, Agile, Scrum Master) and/or GAMP 5 and CSV validation are highly desirable.