Stacia Kurianova | MBA

🌐 Anastacia has a professional career of two decades as a clinical trials executive, business performance strategist,global auditor & keynote healthcare expert. She is considered as one of the most forefront thinkers on the digital transformation in clinical trials. Her performance focuses investigation of intersection of science & business intelligence in order to improve productivity, processes & life of patients. She also runs corporate training sessions & presentations on the topics of holistic medicine, psychology, business intelligence and biohacking. Mrs. Kurianova has advised senior management, consulted government organizations, lectured in top universities, acted as a key person in numerous projects in EU.
🎓 Areas of expertise: GM, Lean Six Sigma, Agile, Keizen,QMS,OpeX,Regulatory Affairs,Clinical Supply Chain,Validation & Qualification, KPIs, P&L, Performance & Change Management, Staffing, Federal Practice, Coaching, Standards Development, Financial Planning & Strategy, Process Improvement,Licensing.
💼 Summary of Qualifications:
✔️ IRCA & ISO 9001-2008/2011/15 Certified Auditor
✔️Extensive expertise of ICH GxPs & relevant regulatory requirements (eg US, EMEA) ✔️Auditing & Observation as a tool of Management strategy, Quality Assurance & Control
✔️Training & coaching | mentoring |vendor management
✔️Process Validation|Equipment Qualification ✔️Clinical Supply Chain Management ✔️Controlled drugs III-V Schedules handling & management
✔️Regulatory Affairs & Contract Management: DCA, Disclosure Confidentiality Agreement | M&A, MSA | POA, Power of Attorney| International Low|Juridical Surveillance and Support of internal/external corporate affairs | Invoicing & Budgeting | P&L