Project Manager of implementing end-2-end Serialization Track & Trace solution in the Middle East region for UAE and Bahrain.
Scope covered change management for the Serialized Supply Chain, assuring Regulatory Compliance, Master Data change, SAP ATTP and ICH development, setup and validation of Tracelink, SAP ATTP and ICH integration with local 3PL and distributor for reporting on behalf of MAH to authorities, Cross organizational OCM including SOP and Training.
Parallel to implementation, CMO and 3PL partners were onboarded and integrated in the Data Process Flow to TraceLink.
Countries and Authorities in scope:
Global Veeva R&D system implementation
Project Manager and OCM Lead of implementing the Veeva R&D suite of Vaults globally.
The projects also scoped 2 large parallel data migrations from legacy systems into Veeva Vault RIM and Quality Docs.
This strategic program started in 2018 by scoping the investment with focus on management of stakeholder expectations. By implementing Veeva systems it streamlined internal processes and enabled the connection, tracking, monitoring, archiving and notification of one source of data across the organization. It also improved management oversight, trending, reporting, in addition to position Bavarian Nordic as one of the largest pure play vaccines companies.
Vaults implemented: RIM, eTMF, QMS, Quality Docs, Vault Training, Station Manager.
CMC product development for MVA-BN-TAEK-VAC vaccine.
Head of leading the CMC project Phase1 from early development to TOX studies and
production towards IND filing.
Implementing new Stage Gate Model for entry of new CMC products and new PPM tool
Responsible for implementing and developing the PMO project Stage Gate Model to
facilitate the pipeline and production of new vaccines for cancer and infectious diseases.
Development and Implementation of functional PPM system, (Milestone plans, Governance model, resource plans, risk analysis and reporting).
TPC DKK 12 million
Agile Project team 10 full time ? and several part time project members.
Product owner/ Project Manager for new IT system implementation for Sygedagpengeforsikring and Tjenestemandspension
Productowner / Project Manager for development and implementation of the Danish
law ?jobpræmieordningen"
for financial support to long term unemployed Citizens. The assignment is managed for the Ministry of Employment and the Danish Agency for Labour Market and Recruitment ? STAR. The Processing Business System is developed on the ATP?s platform and to disburse about DKK 540 million annually to average 25.000 persons in payment to the Danish unemployed on social assistance. TPC DKK 30 million incl. 3 years operations (TPC development DKK 10 million)
Agile Project team 10 full time ? 55 part time project members.
Project Manager for RFI/RFP procurement of the new Robotics Process Automation
Project Manager for development and implementation of ?NemSMS?
to the Processing Business Systems as Feriekonto, Lønmodtagernes Garantifond, ATP Livslang Pension and Kontanthjælpsloftet/Særlig Støtte. The text system is based on standards Text services for Danish central government, partners and organizations. The system is designed as full automatically and it is generating over 1 million text service to Danish Citizens per year. TPC DKK 8 million. Project team 5 full time ? 20 part time project members.
Project Manager for implementing Digital Post version 2.0 for ATP & Udbetaling
Danmark
System integration and implementation of the mandatory Digital Post from public authorities. The Danish Public Digital Post Act gives ATP and Udbetaling Danmark
Project Manager for development and implementation of Test Automation for regression testing
to all the Processing Business System that is managed and administered at ATP. Identification and analyze the needs to develop the automation of tests. In ATP it is very
Project Manager for several IT development and infrastructure transition projects
for and towards ATPs sourcing partners (KMD, NetCompany, NNIT) Sungard investment system implementation in the Pension Investment department for unlisted assets.
2008 - 2009: Maternity Leave with twins
1999 - 2004: Initiate and implements international campaigns
Role: Alliance/Partner-, Business Manager
Results:
1999 1999: Traveled with my husband primarily in Asia
Role: Enterprise Sales Manager
Customer: WM-data / BFC Data
Certificates
2018 - 20182017 - 2017
2010 - 2011
2010 - 2010
2003 - 2003
1986 - 1987
Research and ongoing training
2020 - 2020
2018 - 2018
2016 - 2016
2015 - 2015
2014 - 2014
2013 - 2013
2002 - 2009
2007 - 2007
2003 - 2003
Profile
Skills
Specialist Skills
Experience
broad knowledge within GxP Project Management and Validation
Summary
2022 - today
Role: Global Program Manager
Customer: NNIT
2018 - 2022
Role: Senior Project Lead Veeva R&D and CMC
Customer: Bavarian Nordic
2009 - 2018
Role: Project Manager, Agile SAFe Product Owner/Scrum Master
Customer: ATP
2004 - 2007
Role: Sales and Business Partner Manager
Customer: Magirus Nordic
1999 - 2004
Role: Alliance/Partner-, Business Manager
Customer: HP / Compaq
1989 - 1999
Role: Enterprise Sales Manager
Customer: WM-data / BFC Data
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