Global Program Manager-Veeva R&D-Serialization SAP ATTP ICH Tracelink-PMO Management- Professional SCRUM Product Owner-Scrum Master-SAFe-PRINCE2-ITIL
Aktualisiert am 14.01.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 06.01.2026
Verfügbar zu: 100%
davon vor Ort: 10%
Projektmanagement
Large Scale Projects
Cross-Functional Management
Track&Trace
Regulatory Compliance
Software Quality Assurance
Agile Methodologies
Digital Strategy
PMO Support
Veeva R&D
SAP ATTP
ICH
SAP Serialization
GxP
CMC development
Migration
Integration
Scrum Master
Scrum Product Owner
SAFe
PRINCE2
ITIL
IPMA
Danish
Muttersprache
English
superior
Nordics
intermediate

Einsatzorte

Einsatzorte

Copenhagen (+50km)
möglich

Projekte

Projekte

1 year 2 months
2024-11 - 2025-12

Digital, Data & IT ? Research & Early Development (Foundational Lab IT)

Senior Project Manager - IT
Senior Project Manager - IT
Lab of the Future, new Greenfield building construction in Maaløv to increase productivity through faster development and First Human Dose. Project Track Lead for part of the IT scope for the new ?lights out? full automated facility. Main responsibility is to scope the deliverables and cost estimation including overall planning for the:
  • IoT/ Edge Platform framework to integrate devices and application for data collection, processing and analysis.
  • RFID Platform to automatically identify and track tags attached to objects as Equipment, Consumables, Chemicals and Samples.
  • AI-powered CCTV solution to leverage advanced AI- technology for immediate detection of events or anomalies in the Laboratory.
Novo Nordisk
Copenhagen
6 months
2024-05 - 2024-10

eID Solution identity and access management platform

International Senior Project Manager - IT
International Senior Project Manager - IT
  • Project Manager and Customer Implementation Lead for eID Solution digital Identity Platform for authentication and identification for banks and public organizations across Europe.
  • Project consultant and PMO services to standardize project implementations for eID Solutions Platform to successfully ensure customer value propositions and contract expectations.
  • The eID Solutions white label digital identity infrastructure platform is fully GDPR, PSD2 and eIDAS compliant according to the latest EU regulation.
Nets/ Nexi Group
Copenhagen
6 months
2023-11 - 2024-04

One GN ? Digital Transformation Program

Senior Project Manager - IT
Senior Project Manager - IT
  • Project Manager to support and drive Data Management and Data Governance for ERP program.
  • Establish and drive the data governance and management for ERP Programme.
  • Drive cross-track and business data efforts to ensure consistency and interoperability. Support data to process alignment across implementation tracks.
  • Ensure compliance with data privacy and compliance requirements. Drive assignment of Data Ownership parallel with implementation of Global Process Excellence. Collaborate with Data Transformation Leads, to ensure client data standards are implemented. Collaborate Data Management Teams to ensure any new data governance efforts.
GN Store Nord
Greater Copenhagen
1 year
2022-06 - 2023-05

Global Track & Trace Serialization implementation within Global Supply Chain

Senior Project Manager ? Pharma and IT agiles Projektmanagement Cross Functional Management SAP Serialization ...
Senior Project Manager ? Pharma and IT
  • Project Manager of implementing End-2-End Serialization Track & Trace solution for the Global Supply Chain 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: 
    • UAE MOHAP & Tatmeen
    • Bahrain National Health Regulatory Authority
agiles Projektmanagement Cross Functional Management SAP Serialization Track & Trace CSV
Galderma, France
Copenhagen
3 years 10 months
2018-07 - 2022-04

various

Senior Program Manager RIM eTMF QMS ...
Senior Program Manager
Program Manager ? IT - Global Veeva Vault Quality, RIM and Clinical system implementation
  • Project Manager and OCM Lead of implementing Veeva Quality, RIM and Clinical suites of Vaults globally. The projects also scoped 2 large parallel data migrations from legacy systems into Veeva Vault Quality Docs, Training documentation and RIM.
  • This strategic program started in 2018 by scoping the investment in a business case 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 LMS Training, Station Manager
Project Manager ? Pharma GMP - Fill/ Finish and release of JYNNEOS Vaccine
  • Managing aseptic fill of Bulk Drug Product for Jynneos (Smallpox / Monkeypox Vaccine) and release for the Canadian Market.
  • Scope covered the first commercial formulation, RA label approval, fill, inspection, packaging, release, cold storage shipment, preapproval by authorities after market authorization of the new fill and finish facility.
Project Manager ? Pharma - CMC Drug Product development and production for Clinical Phase 1 (MVA-BN-TAEK-VAC Cancer Vaccine)
  • Leading all stages of the drug development cycle from early development to TOX studies and production/manufacturing towards release, FDA IND submission and Clinical Phase 1 trials.
Project Manager ? Data Integrity - Implementing and people education of ALCOA+ principles
  • Responsible for implementing global ALCOA+ concept to assure good data management and quality in the production sites.
Project Manager ? Sourcing Project - Sourcing of new HR management system (HRMS)
  • Responsible for the process to source new HRMS system with external partner, include vendor identification and preparation for RFI and RFP.
Project Manager ? CMC Governance - 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).
RIM eTMF QMS Quality Docs Vault Training Veeva R&D Station Manager
Bavarian Nordic
Copenhagen
8 years 10 months
2009-09 - 2018-06

various

Project Manager ? IT Finance
Project Manager ? IT Finance
Project Manager for ?VEU godtgørelse" SAP development for ?Arbejdsgivernes Uddannelsesbidrag? AUB
  • Project Manager for internal SAP IT development and implementation system to manage the Danish law for VEU compensation (Part of the Danish 3 Parts agreement). The assignment was managed for the Ministry of Education and the Danish Agency for IT and Learning ? STIL.
  • The Processing Business System was developed on the ATP SAP platform and domains. The system was designed to disburse about DKK one billion annually to approximate 200,000 payouts to employees or their employer. TPC DKK 12 million Agile Project team 10 full time ? and several part time project members.
Project Manager - IT Public - Implementation of the Danish law "jobpræmieordningen" for financial support to long term unemployed. 
  • The assignment was managed for the Ministry of Employment and the Danish Agency for Labour Market and Recruitment ? STAR.
  • The Processing Business System was developed on the ATP's platform 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 ? IT RPA - RFI/RFP procurement of the new Robotics Process Automation solution software
  • Identification and analyze the needs to keep up the automation of manual rules based back office administrative processes. The system reducing cost and improving accuracy by creating a digital workforce. The project included the process and management within the ATP governed framework and operating model.
  • TPC DKK 5 million. Project team 10 full time project members.
Project Manager ? IT Public - Development and implementation of ?NemSMS? 
  • Development and implementation of "NemSMS" to the Processing Business Systems as Feriekonto, Lønmodtagernes Garantifond, ATP Livslang Pension and Kontanthjælpsloftet/Særlig Støtte. The text system was based on standards Text services for Danish central government, partners, and organizations. The system was designed as full automatically and generates 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 ? IT Public - 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 the right to send digital-only messages, letters, documents, etc. to citizens and businesses as Digital Post.
  • TPC DDK 4 million. Project team 10 part time project members.
Project Manager ? IT-Implementation of Test Automation for regression testing using HP QFT/UTP
  • Development and implementation of Test Automation for regression testing to all the Processing Business System that was managed and administered at ATP. Identification and analyze the needs to develop the automation of tests.
  • At ATP it was very cost-effective to perform regression test, in all major releases of the software products and Processing Business Systems that had a long maintenance life. By identifying areas for automated test ATP increased test coverage, improves accuracy, and saved time and money in comparison to manual testing.
  • TPC DKK 8 million. Project team 5 full time ? 10 part time project members.
Project Manager ? IT - Several IT infrastructure transition projects for and towards ATPs sourcing partners
  • 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
    • Development and Implementation of new print strategy
    • Mainframe exit program
    • SW Release process implementation with Sourcing partner
    • Several IT technical projects e.g., Content Manager, On demand, ITSM web services, Websphere MQ, DB2, IBM Content Manager z/OS, IBM TFIM, Single sign on/ Password Sync. IBM Tivoli, G/On, Citrix, ClearCase, ClearQuest.
ATP

Aus- und Weiterbildung

Aus- und Weiterbildung

Certificate

  • Agile Product Owner
  • Agile Scrum Master
  • IPMA
  • PRINCE 2 Foundation
  • ITIL Foundation v.3

Research and ongoing training
2024
eID Academy, Estimation, Uncertainties and Improvement, Michael Berth 7N

2020
  • Appreciative and Empathic Communication, Gitte Brandenburg Carlsen, Teknologisk Institut.
  • GDP practice and course, Camilla Lundbye Castle, Tina Brouer, Pharmakon.

2018
  • GMP for IT responsible. Validation and operation of computer systems subject to GMP, Anders Vidstrup, Pharmakon.
  • SAFe Agil development.
  • Drawing promotes understanding - graphical facilitation, Katrine Raae Søndergaard, Implement Consulting Group.

2016
  • Feedback and communication training towards the project team, Dorte Høyer Adamsen, psychologist.
  • Automation and Customer Journey, Søren Finsel Bisgaard, Vice President, Group Process development, Danske Bank.

2015
Management and Motivation of Knowledgeworker, Senior researcher Helle Hedegaard Hein, Cand Merc and ph. D, CBS.

2014
  • Positive Psychology by cand.psych. Lars Ginnerup, awarded Professor at CBS.
  • Targeted optimization of network and stakeholder - use your network optimally by Susie Lynge, Netværksakademiet.
  • High Performance Team by ATP internal.

2013
  • Agile Project Management by ATP internal.
  • Hogan Assessment personality test. Development of my leadership skills ongoing.
  • Project Managers role in creating motivation by Henrik Bjørnstrup from Bjørnstrup partners.
  • Project Leadership Profile 360° and 6 Leadership Styles by Mannaz.
  • Project management engagement and role in contract negotiation by Lawyer Søren Skibsted, Kromann Reumert.

2007
Training in profitability, earnings, valuations.

2003
Media training by PR agency Dreyer & Kvetny

2002
Ongoing relevant IT management, strategy sales and presentation training

Position

Position

Global Senior Project Manager

Kompetenzen

Kompetenzen

Top-Skills

Projektmanagement Large Scale Projects Cross-Functional Management Track&Trace Regulatory Compliance Software Quality Assurance Agile Methodologies Digital Strategy PMO Support Veeva R&D SAP ATTP ICH SAP Serialization GxP CMC development Migration Integration Scrum Master Scrum Product Owner SAFe PRINCE2 ITIL IPMA

Produkte / Standards / Erfahrungen / Methoden

Profile

  • Result driven Senior Project Manager with experience in Veeva Quality, R&D, CMC, GxP, GmP, LMS Compliance Training, Serialization T&T within Digital Supply Chain, Migration, Digitalization IT and Transition project in the Pharma, Life Science, Finance Industry and Public Sector.
  • The candidate has more than 25 years of professional experience as an IT specialist, where she has worked as a program and project manager for the last 16 years.
  • She has successfully managed large and complex projects with strong and solid cooperative relationship across business units and departments. She takes ownership for and leading strategic global business projects, with many stakeholders, throughout all project phases.
  • She is a result driven Project Manager with focus on delivering on time, on budget and agreed quality. She desires to optimize processes and governance while focusing on the business and client value of the implementation.
  • She is characterized to lead and manage cross-functional teams by coaching and encourage to develop and act. She works structured and keep a holistic overview to achieve the result.
  • She is logical thinking and have good analytical skills. She is empathic and naturally she builds up strong relations. She is a leader, a team player, and an easy-going Project Manager with a lot of energy and laughter.

Skills

  • CMC Drug Product Development
  • GMP Processes and Procedures
  • Veeva Quality, R&D
  • Veeva LMS for GxP training and compliance
  • GxP Computer System Validation
  • Data Integrity (ALCOA+)
  • Data Migration
  • Integration development
  • IT Process and transformation implementation
  • RFI/ RFP and contract negotiation
  • Cloud implementation
  • Masterdata management and clean-up
  • Serialization Track & Trace, Supply Chain
  • TraceLink 
  • SAP ATTP and ICH 
  • 3PL partner implementation 
  • PMO and Governance
  • SAP Application development and maintenance
  • Test Automation

Qualifications
The candidate has extensive knowledge in the field of GxP project management and validation:
  • R&ED ?Lab of the Future?
  • CMC Drug Product development
  • Bulk Production
  • DP Sterile Manufacturing, Fill & Finish
  • Stage Gate Model for GxP
  • Veeva Quality R&D implementations and strategy roadmap
  • Veeva LMS for GxP training and compliance
  • GxP Computer System Validation
  • Data Migration
  • Integration development
  • IT Process and transformation implementation
  • Masterdata management and clean-up
  • SAP Application development and maintenance
  • Serialization Track & Trace
  • Tracelink, SAP ATTP and ICH implementations with 3PL partners
  • RPA Robotics Process Automation (BluePrism) implementation and tender management

Experience
  • 4 years Veeva Quality R&D (Quality, QMS and LMS training) implementation as Project Manager 
  • 2 years Tracelink Serialization T&T implementations as Project Manager 
  • 3 years managing CMC in a GMP environment as Project Manager 
  • 5 years PMO Management and CMC Stage Gate model implementation 
  • 15 years Business and IT Development Project Manager 
  • 4 years Mentor for Graduating Program 
  • 6 years IT Strategy and innovation development 
  • 9 years IT Enterprise Sales and Partner Management

Branchen

Branchen

  • Pharma
  • Finance
  • Public
  • IT

Einsatzorte

Einsatzorte

Copenhagen (+50km)
möglich

Projekte

Projekte

1 year 2 months
2024-11 - 2025-12

Digital, Data & IT ? Research & Early Development (Foundational Lab IT)

Senior Project Manager - IT
Senior Project Manager - IT
Lab of the Future, new Greenfield building construction in Maaløv to increase productivity through faster development and First Human Dose. Project Track Lead for part of the IT scope for the new ?lights out? full automated facility. Main responsibility is to scope the deliverables and cost estimation including overall planning for the:
  • IoT/ Edge Platform framework to integrate devices and application for data collection, processing and analysis.
  • RFID Platform to automatically identify and track tags attached to objects as Equipment, Consumables, Chemicals and Samples.
  • AI-powered CCTV solution to leverage advanced AI- technology for immediate detection of events or anomalies in the Laboratory.
Novo Nordisk
Copenhagen
6 months
2024-05 - 2024-10

eID Solution identity and access management platform

International Senior Project Manager - IT
International Senior Project Manager - IT
  • Project Manager and Customer Implementation Lead for eID Solution digital Identity Platform for authentication and identification for banks and public organizations across Europe.
  • Project consultant and PMO services to standardize project implementations for eID Solutions Platform to successfully ensure customer value propositions and contract expectations.
  • The eID Solutions white label digital identity infrastructure platform is fully GDPR, PSD2 and eIDAS compliant according to the latest EU regulation.
Nets/ Nexi Group
Copenhagen
6 months
2023-11 - 2024-04

One GN ? Digital Transformation Program

Senior Project Manager - IT
Senior Project Manager - IT
  • Project Manager to support and drive Data Management and Data Governance for ERP program.
  • Establish and drive the data governance and management for ERP Programme.
  • Drive cross-track and business data efforts to ensure consistency and interoperability. Support data to process alignment across implementation tracks.
  • Ensure compliance with data privacy and compliance requirements. Drive assignment of Data Ownership parallel with implementation of Global Process Excellence. Collaborate with Data Transformation Leads, to ensure client data standards are implemented. Collaborate Data Management Teams to ensure any new data governance efforts.
GN Store Nord
Greater Copenhagen
1 year
2022-06 - 2023-05

Global Track & Trace Serialization implementation within Global Supply Chain

Senior Project Manager ? Pharma and IT agiles Projektmanagement Cross Functional Management SAP Serialization ...
Senior Project Manager ? Pharma and IT
  • Project Manager of implementing End-2-End Serialization Track & Trace solution for the Global Supply Chain 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: 
    • UAE MOHAP & Tatmeen
    • Bahrain National Health Regulatory Authority
agiles Projektmanagement Cross Functional Management SAP Serialization Track & Trace CSV
Galderma, France
Copenhagen
3 years 10 months
2018-07 - 2022-04

various

Senior Program Manager RIM eTMF QMS ...
Senior Program Manager
Program Manager ? IT - Global Veeva Vault Quality, RIM and Clinical system implementation
  • Project Manager and OCM Lead of implementing Veeva Quality, RIM and Clinical suites of Vaults globally. The projects also scoped 2 large parallel data migrations from legacy systems into Veeva Vault Quality Docs, Training documentation and RIM.
  • This strategic program started in 2018 by scoping the investment in a business case 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 LMS Training, Station Manager
Project Manager ? Pharma GMP - Fill/ Finish and release of JYNNEOS Vaccine
  • Managing aseptic fill of Bulk Drug Product for Jynneos (Smallpox / Monkeypox Vaccine) and release for the Canadian Market.
  • Scope covered the first commercial formulation, RA label approval, fill, inspection, packaging, release, cold storage shipment, preapproval by authorities after market authorization of the new fill and finish facility.
Project Manager ? Pharma - CMC Drug Product development and production for Clinical Phase 1 (MVA-BN-TAEK-VAC Cancer Vaccine)
  • Leading all stages of the drug development cycle from early development to TOX studies and production/manufacturing towards release, FDA IND submission and Clinical Phase 1 trials.
Project Manager ? Data Integrity - Implementing and people education of ALCOA+ principles
  • Responsible for implementing global ALCOA+ concept to assure good data management and quality in the production sites.
Project Manager ? Sourcing Project - Sourcing of new HR management system (HRMS)
  • Responsible for the process to source new HRMS system with external partner, include vendor identification and preparation for RFI and RFP.
Project Manager ? CMC Governance - 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).
RIM eTMF QMS Quality Docs Vault Training Veeva R&D Station Manager
Bavarian Nordic
Copenhagen
8 years 10 months
2009-09 - 2018-06

various

Project Manager ? IT Finance
Project Manager ? IT Finance
Project Manager for ?VEU godtgørelse" SAP development for ?Arbejdsgivernes Uddannelsesbidrag? AUB
  • Project Manager for internal SAP IT development and implementation system to manage the Danish law for VEU compensation (Part of the Danish 3 Parts agreement). The assignment was managed for the Ministry of Education and the Danish Agency for IT and Learning ? STIL.
  • The Processing Business System was developed on the ATP SAP platform and domains. The system was designed to disburse about DKK one billion annually to approximate 200,000 payouts to employees or their employer. TPC DKK 12 million Agile Project team 10 full time ? and several part time project members.
Project Manager - IT Public - Implementation of the Danish law "jobpræmieordningen" for financial support to long term unemployed. 
  • The assignment was managed for the Ministry of Employment and the Danish Agency for Labour Market and Recruitment ? STAR.
  • The Processing Business System was developed on the ATP's platform 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 ? IT RPA - RFI/RFP procurement of the new Robotics Process Automation solution software
  • Identification and analyze the needs to keep up the automation of manual rules based back office administrative processes. The system reducing cost and improving accuracy by creating a digital workforce. The project included the process and management within the ATP governed framework and operating model.
  • TPC DKK 5 million. Project team 10 full time project members.
Project Manager ? IT Public - Development and implementation of ?NemSMS? 
  • Development and implementation of "NemSMS" to the Processing Business Systems as Feriekonto, Lønmodtagernes Garantifond, ATP Livslang Pension and Kontanthjælpsloftet/Særlig Støtte. The text system was based on standards Text services for Danish central government, partners, and organizations. The system was designed as full automatically and generates 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 ? IT Public - 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 the right to send digital-only messages, letters, documents, etc. to citizens and businesses as Digital Post.
  • TPC DDK 4 million. Project team 10 part time project members.
Project Manager ? IT-Implementation of Test Automation for regression testing using HP QFT/UTP
  • Development and implementation of Test Automation for regression testing to all the Processing Business System that was managed and administered at ATP. Identification and analyze the needs to develop the automation of tests.
  • At ATP it was very cost-effective to perform regression test, in all major releases of the software products and Processing Business Systems that had a long maintenance life. By identifying areas for automated test ATP increased test coverage, improves accuracy, and saved time and money in comparison to manual testing.
  • TPC DKK 8 million. Project team 5 full time ? 10 part time project members.
Project Manager ? IT - Several IT infrastructure transition projects for and towards ATPs sourcing partners
  • 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
    • Development and Implementation of new print strategy
    • Mainframe exit program
    • SW Release process implementation with Sourcing partner
    • Several IT technical projects e.g., Content Manager, On demand, ITSM web services, Websphere MQ, DB2, IBM Content Manager z/OS, IBM TFIM, Single sign on/ Password Sync. IBM Tivoli, G/On, Citrix, ClearCase, ClearQuest.
ATP

Aus- und Weiterbildung

Aus- und Weiterbildung

Certificate

  • Agile Product Owner
  • Agile Scrum Master
  • IPMA
  • PRINCE 2 Foundation
  • ITIL Foundation v.3

Research and ongoing training
2024
eID Academy, Estimation, Uncertainties and Improvement, Michael Berth 7N

2020
  • Appreciative and Empathic Communication, Gitte Brandenburg Carlsen, Teknologisk Institut.
  • GDP practice and course, Camilla Lundbye Castle, Tina Brouer, Pharmakon.

2018
  • GMP for IT responsible. Validation and operation of computer systems subject to GMP, Anders Vidstrup, Pharmakon.
  • SAFe Agil development.
  • Drawing promotes understanding - graphical facilitation, Katrine Raae Søndergaard, Implement Consulting Group.

2016
  • Feedback and communication training towards the project team, Dorte Høyer Adamsen, psychologist.
  • Automation and Customer Journey, Søren Finsel Bisgaard, Vice President, Group Process development, Danske Bank.

2015
Management and Motivation of Knowledgeworker, Senior researcher Helle Hedegaard Hein, Cand Merc and ph. D, CBS.

2014
  • Positive Psychology by cand.psych. Lars Ginnerup, awarded Professor at CBS.
  • Targeted optimization of network and stakeholder - use your network optimally by Susie Lynge, Netværksakademiet.
  • High Performance Team by ATP internal.

2013
  • Agile Project Management by ATP internal.
  • Hogan Assessment personality test. Development of my leadership skills ongoing.
  • Project Managers role in creating motivation by Henrik Bjørnstrup from Bjørnstrup partners.
  • Project Leadership Profile 360° and 6 Leadership Styles by Mannaz.
  • Project management engagement and role in contract negotiation by Lawyer Søren Skibsted, Kromann Reumert.

2007
Training in profitability, earnings, valuations.

2003
Media training by PR agency Dreyer & Kvetny

2002
Ongoing relevant IT management, strategy sales and presentation training

Position

Position

Global Senior Project Manager

Kompetenzen

Kompetenzen

Top-Skills

Projektmanagement Large Scale Projects Cross-Functional Management Track&Trace Regulatory Compliance Software Quality Assurance Agile Methodologies Digital Strategy PMO Support Veeva R&D SAP ATTP ICH SAP Serialization GxP CMC development Migration Integration Scrum Master Scrum Product Owner SAFe PRINCE2 ITIL IPMA

Produkte / Standards / Erfahrungen / Methoden

Profile

  • Result driven Senior Project Manager with experience in Veeva Quality, R&D, CMC, GxP, GmP, LMS Compliance Training, Serialization T&T within Digital Supply Chain, Migration, Digitalization IT and Transition project in the Pharma, Life Science, Finance Industry and Public Sector.
  • The candidate has more than 25 years of professional experience as an IT specialist, where she has worked as a program and project manager for the last 16 years.
  • She has successfully managed large and complex projects with strong and solid cooperative relationship across business units and departments. She takes ownership for and leading strategic global business projects, with many stakeholders, throughout all project phases.
  • She is a result driven Project Manager with focus on delivering on time, on budget and agreed quality. She desires to optimize processes and governance while focusing on the business and client value of the implementation.
  • She is characterized to lead and manage cross-functional teams by coaching and encourage to develop and act. She works structured and keep a holistic overview to achieve the result.
  • She is logical thinking and have good analytical skills. She is empathic and naturally she builds up strong relations. She is a leader, a team player, and an easy-going Project Manager with a lot of energy and laughter.

Skills

  • CMC Drug Product Development
  • GMP Processes and Procedures
  • Veeva Quality, R&D
  • Veeva LMS for GxP training and compliance
  • GxP Computer System Validation
  • Data Integrity (ALCOA+)
  • Data Migration
  • Integration development
  • IT Process and transformation implementation
  • RFI/ RFP and contract negotiation
  • Cloud implementation
  • Masterdata management and clean-up
  • Serialization Track & Trace, Supply Chain
  • TraceLink 
  • SAP ATTP and ICH 
  • 3PL partner implementation 
  • PMO and Governance
  • SAP Application development and maintenance
  • Test Automation

Qualifications
The candidate has extensive knowledge in the field of GxP project management and validation:
  • R&ED ?Lab of the Future?
  • CMC Drug Product development
  • Bulk Production
  • DP Sterile Manufacturing, Fill & Finish
  • Stage Gate Model for GxP
  • Veeva Quality R&D implementations and strategy roadmap
  • Veeva LMS for GxP training and compliance
  • GxP Computer System Validation
  • Data Migration
  • Integration development
  • IT Process and transformation implementation
  • Masterdata management and clean-up
  • SAP Application development and maintenance
  • Serialization Track & Trace
  • Tracelink, SAP ATTP and ICH implementations with 3PL partners
  • RPA Robotics Process Automation (BluePrism) implementation and tender management

Experience
  • 4 years Veeva Quality R&D (Quality, QMS and LMS training) implementation as Project Manager 
  • 2 years Tracelink Serialization T&T implementations as Project Manager 
  • 3 years managing CMC in a GMP environment as Project Manager 
  • 5 years PMO Management and CMC Stage Gate model implementation 
  • 15 years Business and IT Development Project Manager 
  • 4 years Mentor for Graduating Program 
  • 6 years IT Strategy and innovation development 
  • 9 years IT Enterprise Sales and Partner Management

Branchen

Branchen

  • Pharma
  • Finance
  • Public
  • IT

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