Tissues and cells
- Advising on legal requirements, quality, safety and ethics related to tissue establishment activities (GxP, OECD, WHO, EDQM mv.).
- Advising on egg/sperm donation, screening and risk assessment, adverse reactions etc.
- Upstart of tissue establishments (submissions, reporting, inspection etc.).
- Preparation of all documentation, quality management and acting as Responsible Person.
Privacy and data protection
- Preparing gap-/maturity analyses, risk assessments, audits and other evaluation.
- Mapping of data inventories, systems, data flows and requirements for global markets (EU, UK, US etc.).
- Implementing and operating information security/ privacy programs in alignment with international standards (ISO, NIST etc.).
- Acting as Chief Privacy Officer, Data Protection Officer, EU Representative etc.
Quality management
- Preparing and maintaining frameworks and docu-mentation (ISO 900X, GxP, OECD, WHO etc.).
- Establishing, monitoring and analyzing metrics/indi-cators (trending, ROI, resiliency and maturity).
- Preparing and executing internal/vendor audits.
- Managing inquiries, deviations/non-conformities, complaints and incidents (root causes, corrective actions, change control, reporting etc.).
- Acting as Quality Responsible.