Caroline Blaison

 GDPR expertise : DPO for Clients, support on GDPR matter,

 Quality related activities: audit on behalf of Clients for GxP compliance suppliers assessment, support on Quality Management System matter

QMS implementation in the dedicated Business Units

 QDS management (GED, PAQ), Gap analysis (RQA, GLP), Action plan, training, R&D lab support (data integrity from the ALCOA principles), audit program from the risk approach

Head of QA & HSE US/Fr clinical-stage biotech

Creation & implementation of GxP QMS & HSE policy_

 Member of the Executive Committee

 QDS management (Fr&US), Training (8/year), Deviation & CAPA, Audit (pre-selection, follow up, study report ; GxP);

 Sub-contractors management for quality matter related to :

• IMP activities (QTA, IND, batch records, OOS, change control)

• Clinical activities (TMF, contracts, ICF);

 R&D lab support (equipment & lab qualification, biobanking)

 HSE activities (risk assessment, action plan, training, documents);

 Act as DPO, MR001 ; GDPR)