Karoline Botten Gundersen Email & Phone Number

Norway

Member of Global IT Leadership Team (ITLT)Lead IT support teams across all non-German sites, driving the continuous improvement of IT Service Management processes.Responsible for managing IT support staff currently in five locations: Asker (Norway), Ploermel and Limay (France), Edinburgh (UK), and Tampere (Finland).Spearhead efforts to enhance service delivery and operational efficiency, ensuring alignment with global standards and business objectives.Collaborate with cross-functional teams to optimize support processes, ensuring seamless operations across multiple regions.Advise and support in IT quality management processes, including SOPs and GMP documentation.

Norway

A Global role where I lead our efforts to develop and enhance the IT Service Management framework across NextPharma. Collaborating closely with IT Site Leads and various IT functions, my role focuses on integrating ITIL principles to refine our service delivery. Key responsibilities include:Process Optimization: Continuously improving ITSM processes like Incident, Problem, and Change Management, enhancing response efficiency and service quality.Standardization of Practices: Utilizing Jira Service Desk to standardize ITSM practices across all locations, ensuring consistency and coherence.Communication and Training: Elevating internal IT communications and training within NextPharma to foster a well-informed workforce.Cybersecurity Advocacy: Monitoring and promoting our global cybersecurity awareness program to safeguard corporate assets and data.Oversee global IT policy and SOP landscape to ensure compliance with regulatory requirements.

Asker Kommune, Viken, Norge

Member of Site Leadership Team (SLT)As an Interim IT Site Lead at NextPharma Asker site, I am responsible for establishing and integrating the local IT department into the company's global IT organization. This involves developing processes and policies aligned with the organization's IT standards and goals, while ensuring that IT solutions meet the expectations of the SLT and Global IT. My focus is on creating a robust and efficient IT function that supports the Site in daily operations and development.

Asker Kommune, Viken, Norge

Member of Site Leadership Team (SLT)Led the local IT department through the divestment of the site to NextPharma. Local Project Lead for the overall IT workstream in the divestment and responsible for sub workstream End User Transfer. Role as Business owner for the SAP carveout (Clone & Trim).

Asker, Akershus, Norge

Member of Site Leadership Team (SLT).Program lead for the strategic transformation programs AGILE 4.0Program lead for automation and digitalization in direction Industry 4.0 at Asker manufacturing site.Project Lead implementation of new OT network.Stretegic planning and deployment.Site Digital SPOC

Norway

Asker, Norway

Member of Site Leadership Team (SLT). Change Lead for Takeda Global LEAN Transformation program AGILE at the Asker site. Details under "Projects".Site Communication Partner (Global Manufacturing Supply Global Quality)Focus: Change management, Strategy, Innovation, Digitalization and Automation.

Takeda Asker, Norway

Takeda Global LEAN Transformation program. Project management Support and Change Agent for Management Infrastructure in preparation phase for Agile program in Takeda Asker.

Singen, Baden-Württemberg, Germany

Takeda Global LEAN Transformation program. The role support the local AGILE program in Takeda Singen, Germany. Change Agent for a specific improvement project within Quality . The Pull Forward role is trained and educated to deploy local AGILE program in home site. Key technologies for the site are Sterile, Liquids and Semi-Solids. The main Products​ are Panto iv., Riopan and Omnaris The AGILE program works within three dimensions: Operating System, Management Infrastructure and Mindset & Behaviour.

Asker, Norway

The role support quality assurance and validation (CSV) of SAP and GxP Computerized Systems at the Asker plant. Is quality advisor in projects for new installation or upgrade of GxP computerized system e.g. SAP, WMS, EMS, Automated guided vehicle (AGV), Serialization.Validation Lead and Project Management.Maintenance and continuous improvement of the Quality Management Systems including implementation of global company and regulatory requirements. Process responsible for CAPA. Leader of Validation Steering Committee at the factory.

Norway, Asker

Quality assurance and validation of SAP and GxP Computerized Systems at the Asker plant. Quality advisor in projects for new installation or upgrade of GxP computerized system e.g. SAP, WMS, EMS, Automated guided vehicle (AGV), Serialization.Validation Lead and Project Management.Maintenance and continuous improvement of the Quality Management Systems including implementation of global company and regulatory requirements. Process Responsible for CAPA in EQMS.

Contract ManufacturingMember of Site Leadership Team at Inpac AS.Contributor new business and bid support.Project manager development projects (pharmaceuticals and life science products) and tech transfer for contract manufacturing.Product- and process development, scale-up and validation (IQ, OQ, PQ,PV).Documentation for Marketing Authorization.Cleaning validation.Continuous improvement - GMP, work processes

Quality improvement project. Development and implementation of work process and documentation system for creation and approval of manufacturing recipies (Production Master).Development and implementation of work process for issuance of batch documents.Training of operators in filling out batch manufacturing records (BMR).Improvement of several procedures (SOPs) in Production.Process validation tasks.

Project manager and/or discipline leader for development and implementation of new or changed pharmaceutical products and medical devicesAdvisor to employees and customers related to products and processes.Changes in raw materials, optimization of formulations and manufacturing processes.Planning, implementation and reporting of manufacturing trials in pilot and production.Tech transfer of manufacturing process for new products and manufacturing processes including process validation and cleaning validation.Preparation of regulatory documentation for Marketing Authorization for new and changed products.Preparation of PQR (Product Quality Review), manufacturing part.Professional adviser in deviation handling, change control and risk assessmentProfessional resource with responsibility for training in production.Document review and approvalBid support new product development and/or manufacturing assignments.

Documentation system for Batch Manufacturing Records (SAP & Adobe output)Project Manager; Review of validation status computerized systems (production equipment, analytical systems and production supply systems.)Project member implementation of Engeneering Change Management (ECO) PP module in SAP. Project member implementation of new intranet solution Nycomed Norway.In-plant training

Documentation system for Batch Manufacturing Records (SAP & Adobe output)Key user SAP R/3 PP moduleProject member Internal Documentation System plant AskerProject ManagementProcess validationGMP improvementsIn-plant training

Various positions as project member:Production Masters for BMR's (SAP & Adobe output)Coordinator for operator training.GMP improvementsIn-plant training

Development and maintenance of internal document system. (Internal spesifications and methods for raw materials, bulk and finish product.)GMP-training.

Support to QC department in plant Asker and plant Oslo.Quality control of pharmaceuticals and nutraceuticals (raw materials, bulk, finish product and packaging materials).Internal document system for chemicals used in the laboratory.

Establishment of production masters in new material management system (SAP).

Pharmaceutical manufacturing; Granulation, Tabletting, Coating (sugar) and powder mixtures.

Digitalization And Digital Transformation (7.5 Ects)

Topics: - From industrial to digital economy. - Network economy and transaction costs. - How attention and experience become economic.

Kvalitetsleder Teknologisk Institutt

Obtained the title Quality Manager after completing study modules K01 , K02 , K03 , KV4 and KV8

Kv8 - Revision (Equivalent 5 Ectc)

Knowledge of guidelines for revision of quality systems according to ISO 19011 : 2011. Establishing the audit program . Planning.

K01-Introduction To Quality Management (Equivalent 5 Ectc)

Terms ”Quality” and ”Process”. Principles for Quality Management.Standards for Quality Management ISO 9000 and ISO 9001. Management.

Kv4-Lean Six Sigma With Statistic (Equivalent 5 Ectc)

Statistical methods.Six Sigma and the DMAIC process.

Ko2 – Building Quality Management Systems (Equivalent 5 Ectc)

Quality Policy and Strategy. Customer Focus. Process Mapping. Documentation of the quality system. Structure of the Quality Assurance.

K03 - Improvement Processes (Equivalent 5 Ectc)

Leadership of improvement activities - involvement and motivation Improving the quality and processes LEAN thinking as a tool.

University Foundation Course In Medicine (60 Ects )

A basic university course in medicine with a thorough, broad-based introduction to anatomy, physiology, pathology, pharmacology.

Part Of B.Sc.: Chemistry Courses, Biochemistry, Statistics, Mathematics And German (133 Ects)

Institute of Pharmacy (2002): Participated course in formulation of non-sterile Pharmaceutics

Naturfaglinje