Profil | Editx

Rôles occupés

Project / Program Manager5 - 10 years

Agile

Agile/Scrum

Lean

Miscellaneous

Project Management

Network/Telecom

GSM/GPRS/EDGE

Mgmt Frameworks

PMBOK

Enterprise Tools

Waterfall

Langues

Maternelle Italian

Italian

Maternelle

English

Courant

Français

Courant

Spanish

Moyen

Expériences professionnelles

Since 2015

Regulatory Portfolio Management @ Ontex BV Aalst (BE) - EU&US factories

01 January 2025 - 31 December 2025

Bridge regulatory intelligence to execution for upcoming regulations, reducing response time and increasing efficiency.

Programme Manager for Integrated Medical Device Program @ Ontex BV Aalst (BE)/EU factories

01 October 2021 - 31 December 2024

Embed compliance to US FDA 21 CFR 820 and EU-MDR 2017/745, and close gaps related to Design control and Risk management.

Program Manager for Integrated IVD Improvement Program @ Biocartis BV Mechelen (BE)

01 December 2019 - 30 June 2021

Optimize R&D lifecycle for IVD products, enforce market presence in US and EU, and increase Quality System maturity level.

Project Management Officer @ GSK – Coupling Unit Rixensart (BE)

01 January 2019 - 31 December 2019

Manage operational unit portfolio and support GSK PMO community.

Program Manager for Cleaning Procedure Validation Program @ GSK Wavre/Rixensart (BE)

01 April 2017 - 31 December 2018

Validate cleaning procedures for FDA remediation program.

Program Manager for FDA Quality Improvement Program @ GSK Wavre (BE)

01 March 2015 - 31 October 2016

Implement a remediation plan for a FDA observation and increase Quality culture.

Études et diplômes

Since 1996

Mathematics @ Università degli Studi di Salerno

01 September 1996 - 01 July 2000

Master's degree in Mathematics.

Annamaria De Sio