Tissues and cells
- Advising on/managing legal requirements (e.g. assisted reproduction), quality, safety and business ethics.
- Advising on/managing donor screening, operations/production and sale.
- Upstart of tissue establishments (documentation, application, inspection etc.).
- Acting as Quality Director, Responsible Person, Chief Operating Officer, lead auditor etc.
Privacy and data protection
- Advising on information security and privacy law (EU, UK and US) etc.
- Preparing/managing gap-/maturity analyses, risk assessments, audits and other evaluation.
- Implementing and operating information security/ privacy programs (ISMS/PIMS).
- Acting as Chief Privacy Officer, Data Protection Officer, EU Representative , lead auditor etc.
Quality management
- Advising on/managing quality management (planning, assurance, control and improvement).
- Preparing/managing gap-/maturity analyses, risk assessments, audits and other evaluations.
- Preparing of quality documentation.
- Preparing, implementing and managing og quality frameworks (ISO, GxP, EFQM etc.).
- Acting as Quality Responsible, lead auditor etc.