Jan 2024 – Present · 2 yrs 2 mos · London Area, United Kingdom

• Advisory on strategy and collaboration in life sciences and energy, with a focus on emerging technologies and international reach.

Jan 2011 – Jan 2025 · 14 yrs

Apr 2005 – Jan 2010 · 4 yrs 9 mos · Copenhagen, Denmark

• Helped design and improve the company’s Quality Assurance system, ensuring stronger alignment with FDA and GMP standards.
• Planned and carried out supplier and customer audits to evaluate and elevate quality management systems.
• Led software validation activities and implemented automation solutions to boost quality control performance and reliability.

Jan 2005 – Apr 2007 · 2 yrs 3 mos · Copenhagen, Denmark

• Developed and implemented a supplier audit protocol for IT and automation vendors on behalf of Leo Pharma, ensuring alignment with GMP requirements. The program covered quality management systems, project execution, software validation, change control, disaster recovery, and regulatory readiness.
• Performed supplier audits based on this protocol, helping strengthen supplier oversight, reduce compliance risks, and support operational quality improvements for Leo Pharma.

Jul 2003 – Apr 2007 · 3 yrs 9 mos · Copenhagen, Denmark

• Contributed to the development of the company’s QA system and conducted internal audits to strengthen compliance with FDA and GMP requirements.
• Performed external audits at suppliers and customers, to assess and improve quality systems.
• Executed software validation and introduced automation tools to enhance quality control efficiency.

Dec 2001 – Jun 2003 · 1 yr 6 mos · Copenhagen, Denmark

• Led IT system audits, validations, and supplier assessments for pharmaceutical and forensic clients.
• Highlights:
• Planned and executed validation projects (VMP, URS, IQ, OQ, PQ)
• Audited suppliers and IT systems under FDA, EU GMP, and DANAK requirements
• Developed validation templates and quality procedures
• Trained client teams on compliance and audit readiness
• Delivered a full IT system audit and validation at Retsmedicinsk Institut, resulting in the first DANAK accreditation of forensic IT systems in Europe, approved without deviations.

Feb 1997 – Nov 2001 · 4 yrs 9 mos · Uppsala, Sweden

• Successfully handled audits and inspections from the US FDA, ensuring compliance and demonstrating regulatory excellence.
• Ensured product quality through software testing in compliance with FDA regulations.
• Created and implemented the company’s first employee induction manual, streamlining onboarding processes.
• Conducted facility tours in multiple languages, showcasing product excellence to stakeholders.