About

Denmark is internationally recognized for its expertise in healthcare, particularly within the pharmaceutical industry and the fertility sector – two high-profile fields that continue to drive innovation, research, and patient care on a global scale. With a strong academic background and over 25 years of experience across industry, regulatory authorities, and the private sector, I offer specialized consultancy services that help organizations navigate this complex and ever-evolving landscape.

Following the completion of my Master’s degree in Biochemistry from the University of Copenhagen, I held a range of positions within drug development, patient safety, regulatory affairs, and compliance at leading pharmaceutical companies, contract research organizations (CROs), and the Danish Medicines Agency, including Novartis Healthcare, Eli Lilly, Lundbeck, LEO Pharma, and ALK Abelló.

In 2012, I transitioned to the fertility sector, assuming the role of Quality Manager and Responsible Person at a rapidly expanding Danish sperm bank. Over the subsequent eight years, I developed, implemented, and maintained a comprehensive quality management system aligned international standards and guidelines. In my capacity as the company’s Data Protection Specialist/Data Protection Officer, I also established the organization’s information security and data protection framework, ensuring full compliance with the GDPR, national data protection requirements, and industry-specific regulations.

My work integrated strategic, tactical, and operational perspectives, fostering a unified organizational direction in which quality, safety, business ethics, and innovation were closely interconnected. This holistic approach played a significant role in the company’s rapid rise to becoming a leading sperm bank in Europe and an innovator within the global fertility industry.

In 2020, I founded my own consultancy firm and have since combined consulting services with full-time roles in information security and the fertility sector. Beginning in 2023, I served in a key leadership position at a newly established software company – soon to evolve into a chain of Danish sperm banks. I was responsible for site preparation, documentation, data privacy, regulatory applications, permit acquisition, and the oversight of operations and production.

Through LHR Consult, I have so far undertaken the following assignments:

• Setting up/reviewing/managing quality systems, processes and documentation, contracts, websites etc. (SharePoint, D4Infonet, Formatex/DMDC, Novax etc.), executing gap analyses/audits, engagement of service providers, preparing for/follow up on inspections, applying for new/change of permits, and acting as Responsible Person/Quality Responsible for fertility clinics.

• Advising on approval phase, quality processes and legal requirements for sperm bank start-ups.
• Advising on legal requirements to offer “polygenic risk scores” as a service.
• Setting up EDMS, “change control” and “deviation” management systems in biotech company.
• Consulting on data privacy/ethics (AI, healthcare apps, scientific research, secondary use of personal data etc.) in public healthcare sector/biotech company.
• Preparing of gap-/maturity analyses and privacy documentation (GDPR etc.) in public healthcare sector, biotech company and fertility clinics.
• Setting up privacy program (ISO 27001/27701/29100) and acting as Data Protection Officer (DPO) in pharma company.
• Implementing of ISO 27001-standard on info. security in pharma consultancy.
• Advising on med. devices, MDR and ISO 13485 certification in biotech company.

I thrive in dynamic, international environments characterized by shifting and competing priorities, a wide range of tasks, and broad stakeholder engagement. With a strong attention to detail, accuracy, and compliance, I approach challenges across departments, disciplines, and solutions with a holistic mindset. At the same time, I advocate for balance and recognize the importance of pragmatic, action-oriented solutions in this context.

I am a good listener, coach, and motivator, and I collaborate easily and effortlessly across professional groups. My strong communication skills enable me to engage at all levels, build sustainable and trust-based relationships, and convey complex issues in a professional and easily understandable manner.

With a strategic and business-oriented approach, I am experienced in meeting the needs and expectations of stakeholders, delivering results, and providing high-quality solutions – a key prerequisite for customer satisfaction and loyalty, as well as the organization’s long-term success.

For more information on

  • previous employment;
  • training;
  • additional qualifications;
  • recommendations/statements etc.,

please contact me on email/telephone – or see my LinkedIn profile

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