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.
IS Portfolio Manager Quality & Compliance, Clinical Affairs & Regulatory Affairs
bioMérieux
Since January 2024
- Drive portfolio governance and prioritization by evaluating project requests, defining scope, arbitrating priorities and budget allocation depending on the business value
- Lead budget (~3M€) planning and performance tracking, co-building financial forecasts and ensuring alignment between business needs and IS investment strategy
- Act as a key interface between IS and business stakeholders to align on needs, validate solutions, and ensure delivery consistency with organizational strategy
- Oversee end-to-end portfolio delivery, including scoping, roadmap definition, backlog management, and monitoring execution of multiple concurrent projects
- Ensure compliance and quality alignment of IS initiatives, supporting regulatory requirements (e.g., GxP, ISO standards) and enabling robust, auditable processes and systems
IS Business Analyst QC & RD
bioMérieux
March 2018
to December 2023
- Led end-to-end delivery of large-scale LIMS transformation programs, managing upgrade, integration and multi-site rollouts, validation cycles, and go-live readiness for QC laboratories across international locations
- Drove business–IT alignment, translating complex QC & R&D needs into functional specifications (URS/FRS), impact assessments, and test strategies, ensuring regulatory-compliant system design
- Played a key role in strategic digital initiatives (SPOT & MDM R&D), contributing to the implementation of “single source of truth” solutions to centralize product data and structure R&D knowledge bases
- Delivered measurable operational improvements, optimizing laboratory workflows, automating processes, and enhancing system performance, scalability, and user adoption in regulated environments
IS Project Manager and Business Analyst QC & RD - ISR consulting
bioMérieux
March 2015
to February 2018
Consultant
Marcy l'étoile
- Led multiple R&D and QC IT initiatives as IS Project Manager & Business Analyst, driving tool upgrades, feasibility studies, and developments to support new diagnostic assay development and laboratory optimization (Nephrocheck, Tempo Evo, ELN)
- Delivered Process standardization solutions, including SampleBank deployment across international R&D sites and enhancements to global labeling tools for QC/QP activities (CABMLE / GLT)
- Strengthened traceability, data quality, and operational efficiency across R&D and QC environments
R&D Project Manager in Microbiology
Institut Pasteur
April 2011
to October 2014
- Led and coordinated innovative R&D research projects on invasive pulmonary aspergillosis, contributing to both diagnostic strategies (real-time PCR assay optimization) and therapeutic approaches (antifungal mode of action and target identification)
- Drove scientific impact and team development, mentoring laboratory technicians and publishing results (12 peer-reviewed articles + 1 book chapter), strengthening knowledge dissemination in infectious diseases
R&D Project Manager in Molecular Biology
BayerCrospscience
September 2007
to January 2011
- Led and developed an R&D project in plant pathology, focusing on the identification of novel antifungal targets in Magnaporthe grisea (rice blast fungus), contributing to crop protection innovation
- Managed scientific deliverables and funding activities, including grant and final report to stakeholders
- Strengthened team and laboratory practices, mentoring undergraduate students and ensuring compliance with BPL and HSQE standards through regular internal audits
Manufacturing Operator
Merial
July 2003
to August 2023
- Vaccine & Label quality control screening on production Line.
University Diploma in Bio-industries Professional vision. UCLY, LYON
University Catholic of Lyon
September 2007
to January 2011
M. Sc. Cellular and Molecular biology and Oncology. Specialty: Functional Genetic, Microbiology.
University Claude Bernard Lyon 1
September 2005
to June 2007
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English
Good
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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