Charlotte Borgensgaard

About Charlotte Borgensgaard

I am a Senior Consultant and Project Manager with more than 30 years of experience in the life science industry, primarily within Medical Devices, IVD and Pharmaceutical Primary Packaging.

My experience spans Quality Management, Compliance, Design Control, Regulatory Affairs, R&D and Operations and includes hands-on specialist work, project management and senior leadership roles.

Professional Experience

My experience within Medical Devices and Quality Management dates back to the early 1990s, including several roles at Philips Medical Systems.

Throughout my career, I have worked with Quality Management, regulatory requirements, Design Control, validation, Risk Management, as well as the implementation and optimisation of quality systems and processes in regulated environments.

For more than 16 years, I worked at Gerresheimer/Superfos Pharma within Pharmaceutical Primary Packaging and held increasingly senior Quality & Regulatory roles, ultimately as Global Senior Director Quality & Regulatory Affairs. My responsibilities covered manufacturing sites in Europe, the US, South America and Asia, as well as a global Regulatory Affairs function.

A significant part of my work before becoming a consultant involved establishing, implementing and optimising Quality Management Systems and processes, as well as harmonising and standardising across organisations, business units and manufacturing sites.

I also have extensive experience within Supplier Quality Management, including supplier qualification, quality agreements, definition of requirements and responsibilities, and follow-up of suppliers and external partners.

In addition, I have experience with implementation of IT systems in regulated environments, including software validation, as well as developing and delivering training within Quality Management and related compliance areas.

My international leadership experience includes acquisitions and integration of manufacturing sites, cross-site improvement and standardisation activities, and chairing a global Quality Council across several business units. This background has given me a broad understanding of how Quality and Compliance need to function at strategic, operational and detailed process level.

Consulting Experience

As a consultant, I have primarily worked with Medical Device and IVD companies, providing hands-on specialist support and project management across R&D, Operations and Quality.

In different assignments, I have worked both as part of R&D organisations, within Quality functions and on assignments for Operations. My experience therefore covers development-related, quality-related and operational activities.

My Design Control experience includes direct preparation of design and development documentation as well as Quality- and Compliance-related activities within development projects.

My consulting assignments have included:

  • Design Control and preparation of Technical Documentation
  • MDR and IVDR Compliance
  • Quality Management Systems
  • Risk Management
  • Process Validation
  • Test Method Validation
  • Software Validation
  • Stability Studies
  • Transport Testing
  • Deviations and CAPA
  • Project Management

I am comfortable both driving an assignment and carrying out the detailed specialist work, including preparation of the documentation required to move the assignment forward.

My consulting work has involved assignments across R&D, Operations and Quality, and I am used to working at the interfaces between functions and translating regulatory and quality requirements into solutions that work in practice.

Building, Improving and Standardising

A recurring theme throughout my career has been the establishment and improvement of systems and processes.

I have experience in building Quality Management Systems and processes, optimising existing systems, implementing new ways of working, and harmonising and standardising processes across organisations and manufacturing sites. This enables me to look beyond an individual procedure or compliance issue and understand how it fits into the wider organisation and the overall Quality Management System.

Training and Knowledge Transfer

I have extensive experience in developing and delivering training within Quality Management, regulatory requirements and related quality and compliance processes.

I am used to translating regulatory and technical requirements into practical guidance that can be understood and applied by different functions within an organisation.

Training and knowledge transfer have often been an integral part of implementing new systems, processes and ways of working.

My Approach

My approach is pragmatic, structured and business-oriented.

Having worked at both operational and senior management level, I understand that compliance requirements must not only be interpreted correctly — they must also be translated into solutions that work in practice.

I take the organisation, the applicable requirements and the specific challenge as my starting point before defining the appropriate solution.

I have worked with organisations of different sizes, structures and levels of maturity and therefore recognise that there is rarely one solution that fits every company.

My objective is to create solutions that are compliant, proportionate and workable in practice, while supporting effective processes and progress in the assignment.

I value open communication, transparency and close collaboration with the people involved.

For further information about my professional background, please visit my LinkedIn profile or contact me directly.