In 2012, I assumed the role of Quality Manager and Responsible Person at a small Danish sperm bank. Over the following eight years, I was responsible for developing, implementing, and maintaining the company’s quality management system, both within the EU and internationally. This work was carried out in compliance with local regulatory requirements as well as international standards and guidelines, including ISO 900X/15189, GxP, WHO, and EDQM.

As the designated Responsible Person under the Danish Tissue Act, I ensured that all licensed activities were conducted in accordance with the applicable regulatory framework. This included overseeing traceability, informed consent, contracting, permits and authorizations, employee qualifications and training, documentation and reporting practices, regulatory submissions, and overall quality assurance.

Aligned with corporate strategy, I led the development of a unified approach to quality, safety, and business ethics. Combined with innovative product development and comprehensive customer service, these efforts positioned the organization as a market leader in Europe and an emerging global player in the fertility sector.

After a period at a global consulting firm, I assumed responsibility in 2023 for establishing and implementing quality and data privacy frameworks for a startup, which has since expanded into a chain of Danish sperm banks. In addition, I held the roles of Donor Coordinator and Chief Operating Officer (COO), with overall responsibility for donor recruitment and management, day-to-day operations, and production processes.

Since 2020, I have worked as an independent consultant, providing services to a range of fertility clinics and sperm banks. In these capacities, I have served as quality responsible, Responsible Person, and Data Protection Officer, among other roles (see the “About” section for more information).

I hold multiple certifications in quality/risk/project management (ISO 9001, GxP etc.), auditing and medical genetics. My professional collaborations include work with fertility clinics, sperm banks, general practitioners, laboratories, accreditation bodies, regulatory authorities and ethics committees.

I also actively participate in industry lectures, webinars, networking events, and training activities hosted by national and international fertility organizations such as the IFFS, SRF, ESHRE, EFS, NFS and the DFS.

Based on this experience, LHR Consult offers the following services:

• Providing guidance and professional expertise on tissue/cell activities (egg/sperm, stem cell, cornea etc.), e.g. donation/procurement, testing/screening, processing, preservation, storage, matching/polygenic risk scores, sale, distribution/export, import, assisted reproduction, scientific research – and related legislation/guidelines (DK, UK, DE etc.).
• Providing professional advise on authorization, registration, healthcare professionals obligations, patient rights, permits, organization and management, facilities, staff, equipment and materials, contracts with third parties, documentation and record keeping, reporting obligations, traceability, good tissue practice etc.
• Acting as Responsible Person (Tissue Order §4/5).
• Preparing, implementing and maintaining documentation and  quality/journaling/document management systems according to ISO 900X, GxP, ICH, WHO, ESHRE, EDQM etc. (SharePoint, D4 Infonet, Formatex/DMDC, Novax mv.).
• Risk management of all business areas, e.g. donation/procurement, cross contamination, mix-up’s, storage, distribution, import, recall and return to stock (ISO 31000, ICH/FMEA etc.).