Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic
Sophie VANSPAUWEN

Sophie VANSPAUWEN

Summary

Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.

Overview

28
28
years of professional experience
1
1
Certification

Work History

Third Party Manager (Clinical Supply Chain, Medicine Development & Supply, R&D)

Keyrus lifescience
02.2022 - Current
  • 6 month Pharma Project : Label Reconfiguration Activities for Fusion PMD, MDS
  • Master activities related to Packaging (Packaging Requests Forms), ensure in system,the traceability of material and production managed by the Third Party
  • Participate in all operational meetings to ensure a good operational progress, be responsible for reporting (KPI, monthly)
  • Create and approve Vaccines master label content according to existing processes, following regulatory and translations requirements specific to each modality
  • Liaise with the Clinical Interface/CTSM teams to create the label content and manage additional translations with the Authorized translator
  • Perform (with QA) quality critical checks of label content produced in various languages to ensure quality right first time across all elements of the label creation process, in a timely manner
  • Collaborate on ad-hoc projects according to SME requirements: Process improvement, GEMBA, root cause analysis, problem solving solution, change control (documentation review)

Operations Process Designer

Clinigen/CSM
03.2017 - 01.2022
  • Creation of the project specific documentation; creation and review of batch records, from Ato7
  • Design processes while balancing quality checks, and process efficiencies
  • Provide support and partner with Quality Assurance, Project Managers, and other departments to ensure compliance of SOPs and respond to and correct errors in a timely manner
  • Assistance to the Project Managers in the setup and the daily conduct of their studies, encoding of study specific details into the ERP system CEMS
  • Provides distribution solutions for cold chain supplies and controlled temperature shipments needs
  • Reviewing internal requests for Production/Distribution/Destruction, verifying of stock levels and inform the Project Manager in a timely manner, tracking & Tracing of shipments and AOR until final delivery
  • Achievement : Supporting the quality department due to the pandemic crisis: review of relevant documentation before batch release (regulatory, cold chain, batch records, excursion of temperature), initiation of deviations and follow-up of CAPAS, audits and inspections

Administrative Assistant (Bulk Viral Production)

GSK Vaccines
02.2016 - 02.2017
  • MPU Administrative support, internal and external meetings organization, writing up reports highlighting actions and decisions, reviewing and printing of batch records and blisters, travel and expense notes, badge clearance, mailing , events organization for the staff, office supply orders
  • SAP Time Management : DTT, HS, irregularities, treatment of errors, closure of employees and workers
  • ESOP : revision, updating and printing of SOPs
  • Link and follow-up with EHS, follow-up of CAPA, KPI costs and KPI quality, incident handling
  • Information support / communication role : ensuring the information platform within the department
  • Achievement : Improvement of archive management, updating in partnership with the QA of the archive room, creation of a new system that facilitates the search and consultation of archives (storage, classification, updating files)

Executive Assistant (Grants & Donations, Medical Governance)

GSK Vaccines
07.2015 - 02.2016
  • Grants & Donations administrative support
  • Follow-up of contracting with Legal, Business Owners and Admins
  • Set-up and maintenance of Easydoc Documentum Community and Team site, set-up and maintenance intranet
  • Interaction with Finance and leading projects/process improvements related to grants financial payments (arrange meetings, minutes, lead topic, and follow-up)
  • Monitoring/controls of SAP Finance grant payments, provide advice/support to Business Admin's for payments grants
  • Financial Disclosure: support in the process of monitoring and provision of information to allow EFPIA and US public disclosure
  • Writing of processes/guidance/flowcharts; maintaining Dashboard information and generate quarterly metrics on grants
  • Creation of a new process to handle, fill and review grant dossier in partnership with Finance, Legal and Governance

Executive Assistant, SECURITAS sa (Facilities Management)

GSK Vaccines
09.2009 - 07.2015
  • Secretarial Management for SECURITAS sa Branch Managers, agendas, e-mails, telephone, organizing and follow-up of business trips, orders
  • Administrative support to 150 Security guards (salaries, economic unemployment, management of annual leave, insurance)
  • Business correspondence, e-mails, reports in French, Dutch and English
  • Organization of internal and external meetings from A to Z
  • Research, archiving
  • Creation of shopping carts and follow-up of SAP payments
  • Organisation and implementation of security for extraordinary visits, such as the visit of the King or the Chinese diplomatic corps

Executive Assistant

CISSOID
06.2008 - 08.2009
  • Secretarial Management to the CEO, Managers and Sales (agendas, business trips, meetings, writing letters, compiling reports using Power Point, catering, etc.)
  • Accounting assistant (encoding and follow-up of invoices, reminders), management of the personnel, (salaries, insurance, car fleet, management of annual leave, etc.)
  • Organization and follow-up of consignments to American clients and suppliers

Administrative and Commercial Secretary

Golf de la Bawette
06.2006 - 05.2008
  • Managing the President's and Golf Club's agendas, organizing meetings and events (catering, booking venues, logistical support, reports)
  • Welcoming visitors, managing members (memberships, organizing competitions)
  • Updating website, telephone, correspondence, filing, archives

Chef, Hostess and Sailor on Board Sailing Yachts

BCR Agency
01.1997 - 05.2006
  • Company Overview: Mediterranean, West Indies and Pacific boat industry
  • Management of the interior maintenance of the yacht, follow-up of renovations to be made
  • Maintenance of the boat in shipyards, financial support to the architect
  • Planning cruises and looking after clients
  • Definition of the budget, accounting, logistics
  • Organizing clients' meals (supplies, creation of menus and cooking meals)
  • Administrative, financial and sailing support to the skipper
  • Make your passion your profession with a lot of cross-cultural richness
  • Mediterranean, West Indies and Pacific boat industry

Education

Bachelor - Communication

ISIS Liege
06.1994

Foreign languages certificate -

ILT CLT
06.1995

CPS' diploma - Catering

Hotel Management School Liege
06.2003

Skills

  • Clinical Supply and Cold Chain

  • Deviations

  • CAPA's

  • Quality Assurance

  • Good Manufacturing Practices (GMPs)

  • Organization

  • Communication

  • Stress resilient

  • Prioritization

  • Flexible

  • Independent

  • Proactive

  • Analytical

  • SAP

  • Veeva

  • Workday

  • Microsoft Package

  • Adobe

  • Prisym Medica, Prisym 360°

  • ChatGPT

Certification

  • Prisym 360, SMART-LS, SAP, Documentum, Workday, MS Office, At Office
  • First aid training (and refresh course), Several places in the world, 01/18, ongoing

Languages

English
Bilingual or Proficient (C2)
Dutch
Bilingual or Proficient (C2)
Spanish
Upper intermediate (B2)

Timeline

Third Party Manager (Clinical Supply Chain, Medicine Development & Supply, R&D)

Keyrus lifescience
02.2022 - Current

Operations Process Designer

Clinigen/CSM
03.2017 - 01.2022

Administrative Assistant (Bulk Viral Production)

GSK Vaccines
02.2016 - 02.2017

Executive Assistant (Grants & Donations, Medical Governance)

GSK Vaccines
07.2015 - 02.2016

Executive Assistant, SECURITAS sa (Facilities Management)

GSK Vaccines
09.2009 - 07.2015

Executive Assistant

CISSOID
06.2008 - 08.2009

Administrative and Commercial Secretary

Golf de la Bawette
06.2006 - 05.2008

Chef, Hostess and Sailor on Board Sailing Yachts

BCR Agency
01.1997 - 05.2006

Foreign languages certificate -

ILT CLT

Bachelor - Communication

ISIS Liege

CPS' diploma - Catering

Hotel Management School Liege

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Sophie VANSPAUWEN