Anastacia Edwards-Kurianova, Mba Email and Phone Number
🌐 I have a rich & diverse professional background spanning over two decades, where I have excelled as a clinical trials executive, business performance strategist, global auditor, and keynote expert. Renowned for my expertise in digital transformation within clinical trials, I am widely regarded as one of the foremost thought leaders in this field. My career is dedicated to investigating the intersection of science and business intelligence, with a primary focus on enhancing productivity, optimizing processes, and ultimately improving the lives of patients. In addition to my corporate SME sessions presentations, where I delve into topics such as integral medicine, psychology, business intelligence, I have had the privilege of advising senior management, consulting government organizations, and lecturing at esteemed universities. Throughout my journey, I have played a pivotal role in numerous projects across the EU, cementing reputation as a key figure driving innovation & progress in the healthcare industry.🎓 Areas of expertise:GM, AI, DeFi,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) ✔️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🗣️BOOK me as a speaker: 📧stacia.kurianova@outlook.at#AI #DeFi #supplychain #pharmaceuticals #biotech #lifesciences # healthcare #speaker #artificialintelligence #biohacking #digitaltransformation #advising #consulting #quality #leadership #business #futureofwork#linkedin
Zentech
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FounderZentech Aug 2024 - PresentGlobal
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Business ConsultantSk Consulting Dec 2020 - Present🌍WorldwideHighly experienced & innovative Pharma Supply Chain Consultant with a dedicated focus on Quality Assurance (QA) and Artificial Intelligence (AI) integration. Proven track record in providing comprehensive solutions for pharmaceutical supply chain management, streamlining processes, and optimizing operations.Possess extensive knowledge in Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other regulatory guidelines within the pharmaceutical industry. Demonstrated expertise in the design, implementation, and management of QA systems, ensuring stringent adherence to quality standards, reducing risk, and maintaining compliance.Proficient in leveraging AI technologies to enhance supply chain visibility, forecast accuracy, and overall operational efficiency. Skilled in deploying Machine Learning algorithms, predictive analytics, and automation tools to support decision making and drive supply chain innovation.Renowned for strategic thinking, problem-solving ability, and a collaborative approach to working with cross-functional teams. Committed to delivering excellence, driving continuous improvement, and achieving business objectives in the dynamic pharma industry. -
Co-FounderSk Transnational Agency®️ Dec 2020 - Present -
Regional Director, Emea | Africa & Middle East Clinical Trial DistributionMarken Aug 2021 - Jan 2024🔹Oversee region depot operations, ensuring efficient and compliant processes. Implement strategic plans for enhanced productivity, cost-effectiveness, and quality across all depot operations.🔹Manage clinical trial distribution clusters within the region. Develop and execute strategies for performance optimization and growth, including expansion into new markets and improvement of existing operations.🔹Lead and manage the region CTD team. Foster a culture of high-performance, continuous improvement, and learning. Implement talent development programs and ensure a robust succession plan is in place.🔹Drive operational excellence in QA. Ensure compliance with all relevant regulations and standards. Implement a proactive approach to risk management, improving overall quality and reliability.🔹Responsible for the P&L of the region. Oversee budgeting and financial forecasting, ensuring financial health and sustainability. Implement strategies to enhance revenues and manage costs effectively.🔹Develop and execute strategies for the establishment of new distribution sites. This includes location scouting, feasibility studies, financial analysis, and operational planning.🔹Collaborate with cross-functional teams and manage relationships with external partners and stakeholders. Develop strategic partnerships for enhanced service delivery and customer satisfaction.🔹Monitor and report on key performance indicators, taking necessary actions to maintain and exceed performance targets. Ensure data-driven decision making and continuous improvement in all operations.🔹Drive the development and execution of strategic initiatives that align with the company's overall vision and goals. This includes market expansion, service diversification, and innovation in service delivery.🔹Direct the development of new clinical distribution sites, overseeing site selection, construction, and operational setup. -
Regional Director Depot Operations Russian Federation & UkraineMarken Mar 2021 - Sep 2021Moscow City, Russia• Supervise overall operations of the company’s Eastern Europe cluster. • Direct all facets of regulatory, quality, operational, and financial affairs.• Align operations of the Eastern Europe Distribution Centers to comply with a legal regulations and company guidelines. • Interface with an array of global stakeholders & process owners to support, maintain quality and operational excellence (Legal, Marketing, HR, Quality, Business Development). • Chart successful course of development, generation, and management of KPI matrix to monitor operations performance. • Liaise with various departmental teams to conduct global audits and regulatory inspections. • Pilot the generation of P&L ,CAPEX statements and convey information to relevant parties. • Serve as key contributor to new staff hiring process. • Act as local system owner and support authorship for Global SOP System Act.
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Country Depot Head & Technical DirectorMarken Feb 2015 - Mar 2021Moscow, Russian Federation• Build company image by collaborating with customers, government, community organizations, and employees; enforcing ethical business practices.• Increase management's effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities.• Develop strategic plan by studying technological and financial opportunities; presenting assumptions; recommending objectives.• Accomplishes subsidiary objectives by establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections.• Coordinate efforts by establishing procurement, production, marketing, field, and technical services policies and practices; coordinating actions with corporate staff.• Support quality service by establishing and enforcing organization standards.• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.• Contribute to team effort by accomplishing related results as needed.
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Head Of Quality Assurance GroupSanaclis Service Limited Apr 2008 - Oct 2014Quality Management & Control, Audit Analysis, pursue• Develop QA plans for assigned products/functional projects,based on an assessment of compliance and regulatory risk• Support Health Authority inspection Preparation, execution and follow-up activities.• Execute change control activities according to the internal Change Control process.• Identify areas for potential enhancement of stakeholder processes to ensure appropriate controls in an evolving bisiness model • Audit Planning, Observation, Conduct.• Corrective and preventive action workshop.• Maintain all activities related to Complaint handling process within External Supply. Ensuring compliance according to the internal quality standards, relevant regulatory requirements and the filed product quality standards.• Record keeping.• Mentoring, trainings and coaching.• Surveillance over Operational Department.• Deliver staff GMP,GCP, GDP, SOP's trainings, reciprocal review of training materials.• Standard Operating Procedures revision• Development and implementation the annual agenda for company strategy in line with the business plan• Maintenance of succession plan for all departments • Risk assessment and mitigation surveillance• Presentations and negotiations pursue • Assist with regulatory inspections or corporate audit activities -
Regulatory Affairs ManagerSanaclis Service Limited Feb 2006 - Apr 2008Regulatory Affairs & Contract Management• Contract elaboration & budgeting/invoicing activities• Management costs to budget • Ensure Agents' full compliance with the Company's and local regulators' Anti-Money Laundering procedures, working with the relevant resources in the Legal Affairs team.• Check the product aligns with market expectations, external policies and laws as well as internal policies• Support the local operations on relevant legislation changes• Provide management with implementation of department strategies and policies• Manage compilation, organization and preparation of technical data for product development and registration submissions.
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Logistics & Data Management SpecialistSanaclis Service Limited Jul 2005 - Feb 2006Logistics & Data Manegement, handling processes involved in a supply chain
• Monitoring the quality, quantity, cost and efficiency of the movement
and storage of goods.
• Coordinating and controlling the order cycle and associated
information systems.
• Analyse data to monitor performance and plan improvements and
demand.
• Allocating and managing staff resources according to fluctuating
needs.
• Meeting and negotiating with customers and suppliers.
• Developing business by acquiring new contracts, analysing logistical
problems and providing new solutions.
Anastacia Edwards-Kurianova, Mba Skills
Anastacia Edwards-Kurianova, Mba Education Details
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Expert Testimonial -
Pricewaterhouse Coopers (Pwc)Master -
Dangerous Goods Including Class 7 Radioactive Material -
3.0 Ama Pra Category 1 Credits -
Credit Accumulation & Transfer Scheme (Cats). Points Awarded 10. -
Clinical Trials -
Moscow State Regional UniversityHonorary Diploma
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Moscow State Regional UniversityHonorary Diploma
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International School Of MicronutritionCpd Certified
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Academy Of It & Information ManagementSpecialist
Frequently Asked Questions about Anastacia Edwards-Kurianova, Mba
What company does Anastacia Edwards-Kurianova, Mba work for?
Anastacia Edwards-Kurianova, Mba works for Zentech
What is Anastacia Edwards-Kurianova, Mba's role at the current company?
Anastacia Edwards-Kurianova, Mba's current role is Seasoned Executive | AI Engineer | GxPs | QMS Auditor | Consultant | Life Sciences Professional | WEB3 | Blockchain Expert.
What schools did Anastacia Edwards-Kurianova, Mba attend?
Anastacia Edwards-Kurianova, Mba attended Stanford University, Pricewaterhouse Coopers (Pwc), Iata Training, Harvard Medical School, University Of Oxford, University Of Cambridge, Moscow State Regional University, Moscow State Regional University, International School Of Micronutrition, Academy Of It & Information Management.
What skills is Anastacia Edwards-Kurianova, Mba known for?
Anastacia Edwards-Kurianova, Mba has skills like Business Strategy, Languages, Sop Development, Coaching Staff, Temperature Mapping, Regulatory Affairs, Quality Auditing, Showcase, Supply Chain Management, Team Management, Training, Validation.
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