I hold a masters’ degree in biochemistry from the University of Copenhagen. For many years I worked in the pharmaceutical industry, contract research organizations (CROs) and the Danish Medicines Agency – focusing on drug development, patient safety and regulatory affairs (Novartis Healthcare, Eli Lilly, Lundbeck, LEO Pharma, ALK Abelló etc.).

In 2012, I took up a new position as Quality Manager/Responsible Person in a fast-expanding Danish sperm bank. Over the next eight years, I developed, implemented and maintained the company quality management system (ISO 900X, GxP, WHO, OECD etc.). Later – in my capacity as Data Privacy Specialist/Data Protection Officer (DPO), I set up the company information security management system/data privacy program (ISO 2700X/277XX etc.) in accordance with the General Data Protection Regulation/GDPR, national data protection acts and special law.

With an eye for the strategic, tactical and operational level, I led the organization in a common direction regarding quality, safety and business ethics. In continuation of this – and as a consequence of an innovative approach to treatment and high quality products, the organization established itself as brand-leading in Europe, and a pioneering player on the global fertility market.

In 2021, I launched my own consulting company, to offer legal advice, quality management, administration of information security/data privacy, preparation of documentation and legal advice related to tissue  & cell activities, pharma and biotech – as well as other academic disciplines of the public/private sector.

Examples of tasks so far:

• Advising on data privacy/ethics related to artificial intelligence, the use of heatthcare apps and scientific research in public healthcare.
• Advising on sperm bank upstart.
• Setting up EDMS, “change control” and “deviation” management systems in biotech companies.
• Auditing of fertility clinics – and acting as Responsible Person.

• Preparing of privacy documentation in pharmaceutical industry.
• Setting up full-scale privacy programs/frameworks and acting as Data Protection Officer.
• Implementing the ISO 27001-standard on information security;
• Advising on medical devices and ISO 13485 certifications.

I thrive in a dynamic and international environment with changing and competing priorities, managing a wide range of tasks and stakeholders across the organization. With an eye for detail and accuracy, I think across departments, professional disciplines and solutions. At the same time, I understand the interplay between ensuring compliance, whilst acknowledging the necessity for pragmatic and actionable solutions.

I am good at listening, coaching and motivating, collaborate easily and effortless across professional groups, and possess exceptional communication skills, enabling me to interact at all levels, build sustainable relations, and convey complex issues in a professional and straightforward way.

With a business-minded focus, I am used to meet the needs and expectations of interested parties, drive operational excellence, create results, and deliver high-quality solutions – important criteria for customer satisfaction/loyalty, and eventually 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.