Beschreibung

Clinical Trials & GxP Consultant | Assay Validation & Regulatory Documentation

Pharmaceutical Industry Expert (GSK background)

Trilingual FR–EN–ES | Bridging science, compliance and operational execution

🔹 Main description

I am a Senior Scientist in the pharmaceutical industry with several years of experience in clinical assay development, validation and regulatory documentation within vaccine and biomarker programs.

My expertise covers clinical trial support, assay qualification/validation (GCLP/GxP), CRO oversight and technical documentation aligned with ICH guidelines.

I contribute to the design, implementation and validation of clinical assays, ensuring scientific robustness, compliance and operational efficiency.

I also support teams in structuring complex regulatory and scientific documentation for submissions, audits and inspections.

🔹 What I offer

• Clinical assay validation & qualification support (GCLP/GxP)

• SOP development and documentation structuring

• Clinical protocol and technical report review

• CRO coordination & scientific oversight

• Risk assessment and compliance support

• Regulatory documentation preparation

🔹 Languages (court et stratégique)

Trilingual professional background:

• French (native)

• English (daily working language in pharma)

• Spanish (professional fluency, lived 4 years in Chile)

Branchenexpertise

Sprachen

Spanisch
Muttersprachlich oder zweisprachig
Französisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher

Arbeitsortpräferenzen

Nur remote

Führt Projekte hauptsächlich remote aus

GSK
Expert Scientist – Clinical Functional Immunology Assay Platform
PHARMAZEUTISCHE INDUSTRIE
Juni 2022 - Heute (4 Jahre)
Wavre, BW, Belgium
Lead scientist for the transfer and validation of neutralization assays to China, US and other countries, ensuring full alignment with ICH Q2 guidelines and internal SOPs.
Coordinated and executed bridging experiment, Assays Qualification and Validation, non-clinical and clinical studies across multiple sites, achieving regulatory acceptance within agreed timelines.
Developed and monitored QC charts and trending(assay stability monitoring, … ), strengthening assay robustness and ensuring long-term data integrity.
Acted as focal point for international collaboration, liaising with cross-functional teams (QA, QC, regulatory affairs, and clinical operations) to ensure smooth assay deployment.
Contributed to risk assessment and mitigation planning, supporting decision-making processes in global vaccine development.
SOP Quality Assurance Qualification validation Regulatory Compliance Risk Assessment
GSK
Lab Manager in vaccines Clinical Immunology – Clinical Readout Lab (CRLab)
PHARMAZEUTISCHE INDUSTRIE
April 2021 - Juni 2022 (1 Jahr und 2 Monate)
Wavre, BW, Belgium
• Manage laboratory activities to support vaccine development programs
• Development of tests and monitoring of clinical vaccine testing activities
• Manage a team of technicians (support, organization, prioritization, capacity management)
• Ensure that the test meets GCLP requirements, and that the documentation complies with GDP practices
• Monitoring of clinical trial activities to support clinical trials
Regulatory Compliance Clinical Trials Protocole de test GxP
Jolimont Group / Federal Covid Platform
Scientific responsable
Oktober 2020 - April 2021 (6 Monate)
Belgium
Scientific responsable attached to the federal COVID19 platform.
Installation of the federal platform to perform PCR detection tests for SARS-CoV2, participation in the high-throughput operation of SARS-CoV2 qRT-PCR tests, virus sequencing (ion torrent technique) management of equipment and teams, training in TECAN