Temporary Head of Quality Management & Regulatory Affairs

Clinical Studies And Regulatory Affairs

• Coordination Of Clinical Evaluations / Performance Evaluations And Usability Studies (Human Factors)
• Design And Conduct Of Clinical Studies (Iso 14155)
• Risk Management (Iso 14971)
• Clinical Studies (Phase I-iv, Pmcf, Eu Mdr)
• Study Documentation (Ecrf)
• Post-market Surveillance (Pms) Studies
• Vaccine Development In Oncology And Virology (Gmp)
• Legal Frameworks
• Planning Of Animal Studies (Preclinical, Felasa, Gv-solas)
• Coordination With Authorities (Bfarm, Pei And Fda) And Notified Bodies (Tüv Süd)
• Patent Drafting According To European (Epo) And Us (Uspto) Standards
• Technology Transfer & Scale-up

Quality Management

• Qms (Iso 9001/13485, Gmp, Fda)
• Audit Preparation And Follow-up (Mdsap, Fda, Mdr, Amg, Gxp)
• Technical Documentation (Product Files)
• Risk Management (Iso 14971, Fmeas)
• Capa Management
• Creation Of Standard Procedures (Sops, Qmh, Hygiene Manual)
• Coordination With Drug Authorities (Bfarm, Pei, Ema, Fda)
• Compliance With International Standards (Gxp, Eu Mdr, Fda 21 Cfr 820 And Iso 9001/13485/14971)

Project Management

• Organization Of Project Environments
• Steering And Adherence To Project Plans
• Efficient Leadership Of Team Meetings
• Linking Project Goals And Stakeholder Interests (Kol Management)
• Leading Project Teams And Business Processes
• Business Administration In Project Management
• Legal Aspects
• Project And Product Marketing
• Project Controlling
• Change Management
• Rational Project Planning And Control
• Implementation Of Goals And Milestones
• Running Multiple Projects
• Technology Transfer (From Preclinical To Gmp)
• Certified Project Manager (Gpm And Ipma, Level D)