Marie-Noëlle Debelle's curriculum vitae outlines her educational background including a Master's in Biology from the Catholic University of Louvain and over 30 years of experience in the pharmaceutical industry, primarily at GlaxoSmithKline Biologicals where she has held several senior management roles focused on quality, risk management, and regulatory affairs.

1. 1
CURRICULUM VITAE
Marie-Noëlle Debelle
e-mail: marie-noelle.m.debelle@gsk.com
1977-1983 CATHOLIC UNIVERSITY OF LOUVAIN (Louvain-La-Neuve)
• Sciences Department
Master in Biology (Zoology), January 83, distinction
Major in Ecology and Toxicology
Thesis topic : “Toxicotolérance de deux espèces d’Oribates Corticicoles au dioxyde
de soufre”
• Post-graduate diploma of “Agrégation” for High School Teaching” in June 83
1971-1977 MARTIN V LYCEE (Louvain-la-Neuve)
Classical Humanities - latin-sciences section
High school diploma in June 77
From Sept 14 GLAXOSMITHKLINE BIOLOGICALS
Senior Manager, Risk Management Lead
Risk Management Process Owner for R&D
Quality & Risk Management Platform/ since Sept 2015 ad interim belonging
to Risk and Performance Management Team within Portfolio Integration and
Operations
Research & Development
• Work closely with Area Leads to ensure a robust framework for Risk
Management (RM) is in place and in use across R&D
• Develop strong network with Vaccines Compliance and R&D leadership to
further embed and grow RM strategy in R&D and to ensure consistent
implementation of agreed strategies
• Act as trainer for Vaccines RM and coach through dedicated workshops
• Build risk facilitator (RF) capabilities through the R&D RF Community of
Practices
• Propose tools and templates to leverage business ownership (e.g. Risk versus
Issue decision tree, R&D risk list, R&D risk map, criteria for good risk
description, guidance for risk scoring and prioritization)
• Be SAP GRC expert and R&D RM Process Owner (RMPO) for SAP granted
access
Last update January 2016
31 years of experience in Pharmaceuticals
Education
Professional Experience

2. 2
• Perform quality checks on priority R&D risks with feedback to relevant risk
facilitators, monitor preparation and plan of priority R&D risks to R&D Risk
Management Board (RMB), generate training compliance reports of pan R&D
risk owners and coordinators
• Generate KPIs on priority risks with monitoring and visibility at RMB
• Generate RMB meeting minutes and action log with circulation to all RMB
members
• Manage a team of up to 3 managers and/or administrative assistant
From Augt 13 GLAXOSMITHKLINE BIOLOGICALS
Senior Manager, VVHS Risk Management Implementation Lead
Vaccine Value & Health Science / Medical Governance
• Lead the implementation of the enhanced risk management framework (RMF)
across VVHS
• Direct, coordinate and supervise the roll-out of RMF by ensuring prompt and
regular communications to relevant impacted people
• Build capabilities of the Quality & Risk Management (QRM) team in
identifying, preparing and/or reviewing risks according to new criteria and
coach them to obtain an efficient risk management process across VVHS
• Collaborate closely with the QRM team and the business to stimulate and
embed risk management within normal practice
• Work closely with RM process owner of VDD and ITx to obtain R&D Risk
Register and optimise the transversal view and effort in the way risks are
managed
From Apr 09 GLAXOSMITHKLINE BIOLOGICALS
Senior Manager, Quality and Risk Management, Global Regulatory Affairs
Vaccine Value & Health Science / Medical Governance
• Lead compliance excellence and quality improvement in the area of Global
Regulatory Affairs across GSK Biologicals VVHS network, including cross-
departmental processes
• Direct, coordinate, supervise and follow up the mutually agreed business risk
register and associated risk treatment plans
• Support the business in audits and inspections e.g. help in preparation,
coordination, hosting of event, guide and advise in wording responses until
completion of CAPAs
• Collaborate closely with the business to stimulate process improvement, do
right first time and strengthen quality excellence
• Lead and develop a collaborator and manage his activities
1987-2009 GLAXOSMITHKLINE PHARMACEUTICALS - BELGIUM
Feb 2001 Manager, Clinical Quality Assurance
Medical Affairs and Clinical Development department
• Ensure adherence to standards of quality and compliance with Good Clinical
Practice regulations/guidelines and GSK policies and procedures (SOPs)
• Identify CR training programs and calendar for new and existing CR staff - Co-
ordinate and/or conduct initial and ongoing GCP and cross-functional process
training
Last update January 2016

3. 3
• Prepare, co-ordinate and/or facilitate audits and Regulatory Inspections – ensure
timely completion of CAPA plan - communicate audit findings, share
experience in their resolution and adapt training accordingly
• Establish, in partnership with the QA unit, internal audits and self-inspection
activities for the Medical Department, e.g. on SOP Management, Training
Records, Training Plans, Clinical Trial Supplies, labels translations, Safety and
Archiving
• Assume the Regional Hub Trainer role for Belgium and the Netherlands
• Promote sharing of best practices and expertise in SOPs, processes and systems
within the Medical Department and across the European Quality network
• Roll-out audit learning’s and audit alerts within the department, stimulating
dialogue to understand how these issues can be addressed at working levels
• Act as active member of the Quality Efficiency Team in charge of the
implementation of QMS requirements within GSK Be organisation
• Participate in the generation of Business Continuity Plans, Pandemic Plans and
Risk Management Plans applying to the Medical Department
• Lead the SOP development and management process, ensuring their effective
roll out
• Supervise the overall Clinical Trial Supplies process to meet the requirements
of GCP, GMP and GDP, and ensure the correct handling of CTS by the CRO in
charge of the local depot
• Lead and develop collaborators and manage their activities
Feb 2000 Clinical Quality Support Manager
Medical Affairs and Clinical Development department
• Ensure and maintain the competitive position of GWB Medical Affairs and
Clinical Development within GSK R&D organisation by driving and enforcing
clinical compliance with regard to GCP, SOPs and regulations
• SOP Management (administration, development and implementation of SOPs)
• ‘Accredited local trainer’ (initial and on-going GCP/SOP training for new and
existing staff)
• Support and expertise in GCP, SOPs and regulations
• Centralised processes for training records, SOP management, Clinical Trial
Supplies, CT labels translations and Archiving
Sept 1997 Quality Assurance Officer
Medical Affairs department
• SOP Management
• Expertise and training of GCP and SOPs
• Coaching of CRAs and assistants, set-up of the co-monitoring process
• Centralised processes for training records, supplies and archiving
1994-1997 Medical Data Scientist and Quality Control
Medical Department
• Validation of clinical data for phase I-III clinical trials
• SOP Administrator
• Local Trainer
• Safety nominee (pharmacovigilance)
Last update January 2016

4. 4
1992-1994 Medical Resources Scientist
Medical Department
• Development and delivery of specific training programmes for internal and
external delegates (CRAs, sales representatives, physicians, investigators)
1989-1992 Clinical Research Scientist
Medical Department
• Writing of protocols and creation of CRFs
• Initiation and monitoring of clinical trials
• Local projects (marketing support) and international (registration purposes)
• Therapeutic areas: gastroenterology and antibiotics
• Training of sales reps for above therapeutics areas
1987-1989 Sales Representative (Informateur Scientifique)
Sales Department
• Public relation activities
• Promotion of pharmaceutical products
• Domains in gastroenterology, pneumology, dermatology and antibiotics
• General practitioners and specialists
1984-1987 GIST-BROCADES LABORATORIES
Sales Representative (Informateur Scientifique)
Sales Department
• Promotion of pharmaceutical products
• Domains in gastroenterology, cardio-vascular, dermatology, paediatrics and
allergology
• General practitioners and specialists
Training, SOPs, GCP and Regulatory Affairs
Sept 2010 Physician Foundation Programme – GSK Biologicals Faculty
May 2010 Guaranteeing Quality for Audit Success – Brussels - Harrison Clinical Research
Mar 2010 Vaccines Initiation Workshop - GSK Bio – Vaccines Academy
May 09- Oct 10 Regulatory Affairs Legislations – GSK Bio – Regulatory Policy group
Nov 2009 Drug Information Association – Paris - European Regulatory Affairs workshop
June 2007 ACRP: How to get prepared for EMEA Inspections and National Competent
Authority
Inspections
Last update January 2016
Training and complementary education

5. 5
Sept 2007 Regulatory Compliance Workshop Group (RCWG): Solving the Problem in
Designing,
Implementing and Managing SOPs for CR
Oct 2006 ECCRT Congress - Brussels - on EU CT Directive and its implementation into B
Law
2005 Member of « Drug Information Association »
Nov 04 DIA congress on EU CT Directive - Paris
Practical implementation and lessons learned
94-08 International Business meetings (2x/year) covering GCP, SOPs and trainer
role
1995 How to detect fraud and misconduct
Workshop - Rostrum - Antwerpen
1997 Challengers for improvement in the area of GCP, independent audits and
inspections - Congrès DIA - Brussels
2002 Solving the problems of managing SOPs in Pharmaceutical Research – Henri Stewart
Conference Studies – Washington DC
Leadership, Communication and sales
Apr-Sept 14 Job plus Coach Program: how to make more impact
June 2013 Practical Coaching in the workplace – 1 day – GSK Biologicals (HR)
Apr 2013 Energy for Performance (3days) – GSK Bilologicals (HR)
Nov 2005 Leading in a complex environment - UK - European Leadership Foundation
2004 Time Management training - Atlas Business Training, Anvers
Sept-Dec 03 Leadership Foundation and Principles - European Leadership Foundation
2003 GSK European Leadership Foundation - 2 workshops - Self as leader and leading
others
1998 Project Team Management
1996 Training skills accreditation process - 3 modules of 3 days
Excel Communication (UK)
1992 Les relations interpersonnelles dans la vente - Wilson Learning
1990 Public speaking
Face to face
1985-1986 Agir sur autrui (10 sessions) - Eric Krauthammer
Marketing
1989 Territory Management
Product Management
1992 Le Marketing pour non-initiés
Last update January 2016

6. 6
Data Management
1994 Glaxo Optimally Linked Database training – internal training (UK) - 10 days
validation process for clinical data
Computer science
2006 Synaps - Brussels - Excel prise en mains
2004 Advanced course Powerpoint - Synaps
1997 Powerpoint 7.0 (Dialog)
MS-Exchange NT 5.0 (Dialog)
Internet (Dialog)
1996 MS-Word 7.0 (Dialog)
MS-Excel 7.0 (Synaps)
1994 Windows (Synaps)
Access (Synaps)
Teaching and student job
1983 3 months interim as teacher at Don Bosco school - Brussels
1979-1981 Secretary office – reception desk at Universtity Halles in LLN
French - mother tongue
Dutch - good knowledge spoken and written
- training : Nederlandse Academie 90/91
Berlitz School 88/89
Cefora 02/03
English - very good knowledge spoken and written
- internal training (1995)
German - basic passive knowledge
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Last update January 2016
Languages

7. 6
Data Management
1994 Glaxo Optimally Linked Database training – internal training (UK) - 10 days
validation process for clinical data
Computer science
2006 Synaps - Brussels - Excel prise en mains
2004 Advanced course Powerpoint - Synaps
1997 Powerpoint 7.0 (Dialog)
MS-Exchange NT 5.0 (Dialog)
Internet (Dialog)
1996 MS-Word 7.0 (Dialog)
MS-Excel 7.0 (Synaps)
1994 Windows (Synaps)
Access (Synaps)
Teaching and student job
1983 3 months interim as teacher at Don Bosco school - Brussels
1979-1981 Secretary office – reception desk at Universtity Halles in LLN
French - mother tongue
Dutch - good knowledge spoken and written
- training : Nederlandse Academie 90/91
Berlitz School 88/89
Cefora 02/03
English - very good knowledge spoken and written
- internal training (1995)
German - basic passive knowledge
ϕϕϕϕϕϕϕϕϕϕ
Last update January 2016
Languages