Tissues and cells
- General advising on tissue establishment requirements, upstart, submissions, reporting, inspections etc.
- Advising on quality, safety and ethical aspects of tissue/cell activities, e.g. procurement, aseptic processing, cryopreservation, distribution, research and use of ART (GxP, OECD, WHO etc.).
- Advising on sperm/egg donor management - enrolment, screening, qualification criteria etc.
- 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 ISO 2700X/ 2770X/29100 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.