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Laetitia Muszkieta

Laetitia Muszkieta

IS Portfolio Manager Quality & Compliance, Clinical & Regulatory Affairs

Porfolio Management
Project Management
Quality Control and Manufacturing
IT Solution Analysis
Non-Product Software Definition
42 years old
Driving License
Lentilly (69210) France
Employed Open to opportunities
As IS Portfolio Manager with over 15 years of experience in life sciences, I am leading digital transformation across Global Quality & Compliance, Manufacturing, and Clinical & Regulatory domains at bioMérieux. I specialize in bridging business, IT, and scientific environments, driving complex programs such as LIMS transformations and data platforms in highly regulated contexts. Today, I focus on portfolio governance, strategic alignment, and value-driven investment decisions, ensuring the delivery of scalable solutions that enhance data governance, operational efficiency, and business performance.
  • English
    Good
  • French
    Expert
  • IT Portfolio governance & prioritization, managing project pipelines, backlog, and value-based decision-making
  • Budget planning, forecasting & financial control (CAPEX/OPEX) across complex project portfolios
  • Roadmap definition & strategic planning, aligning IT initiatives with business objectives and constraints
  • End-to-end project management, from scoping to deployment and go-live
  • Multi-project / multi-site coordination, ensuring delivery across international environments
  • Risk, issue & dependency management in complex and regulated contexts
  • Quotation request
  • Requirements gathering & translation
  • Process analysis and optimization (QC & R&D laboratory workflows)
  • Impact assessment, functional design, and testing strategy definition
  • Data governance & master data management (MDM)
  • System integration (LIMS, SAP, lab Instruments, TWD, BI tools, other digital platforms)
  • Digitalization of laboratory, quality, and R&D processes
  • Stakeholder management across IT, Quality, QC, Manufacturing and Clinical & Regulatory teams
  • Cross-functional collaboration and alignment
  • Workshop facilitation, communication & influencing skills
  • Vendor management and RFI/RFP processes
  • 21CFR part 11 for Non-product Software
  • GMP= Good Manufacturing Practices
  • GCP= Good Clinical Practices
  • ISO 9001, ISO 13485
  • Act as Internal Auditor
  • ISTQB and ITIL guidelines