Katarina Obdukarimova
Geraardsbergen
Summary
Strategic and results-oriented business leader with experience in strategy, planning and operations. Skilled in developing and executing business plans to maximize profitability, streamline operations and maintain compliance with industry regulations. Proven people leader motivates and optimizes staff performance and productivity.
Overview
2025
2025
years of professional experience
10
10
years of post-secondary education
4
4
Certifications
Work History
Head of R&D and Pharmacovigilance Inspection Management, Director
UCB Pharma
6 2022 - Current
- Lead the global R&D and PV Inspection Management team with Quality and Inspection Management Leads in Belgium, China, Taiwan and Japan
- Maintain global GLP, GCP, and GVP Health Authority inspection forecasts, procedures, tools, and inspection intelligence
- Develop and implement inspection preparation and management strategies, including interactions with inspectorates, vendors, and partners
- Drive inspection response strategy
Head of Global Clinical Inspection Management, Director
UCB Pharma
12.2023 - 08.2024
- Coordinated all global GCP inspections, including preparation, conduct, and follow-up
- Developed and maintained global GCP inspection forecasts for regulatory filings across all compounds
- Created an inspection toolbox to facilitate worldwide GCP inspections
- Managed Early & Clinical Development Leads in the Asia Pacific region, including China and Japan
Early and Clinical Development Quality Lead, Associate Director
UCB Pharma
07.2023 - 02.2024
- Ensured global quality and compliance from candidate selection to lifecycle management of UCB compounds
- Provided strategic insights and partnered in development strategy to maintain global quality standards
- Led quality oversight and consultation at the program/study level, ensuring GCP quality and compliance
Global Inspection Management Lead, Associate Director
UCB Pharma
07.2023 - 11.2023
- Led or supported GCP/GLP inspection readiness activities and inspections globally
- Managed Early & Clinical Development Leads in the Asia Pacific region, including China and Japan
Across Compound Inspection Readiness Lead, Associate Director
UCB Pharma
06.2022 - 06.2023
- Led inspection readiness activities by coordinating documents and activities common across compounds and submissions
- Ensured consistency of inspection readiness approach across asset submissions and managed interdependencies across parallel inspection programs
- Contributed to inspection management activities across all compounds
Inspection Lead - Associate Director, Clinical Trial Inspection Management, R&D Quality
Bristol-Myers Squibb
07.2020 - 05.2022
- Led Health Authority GCP inspections worldwide, including inspection readiness, preparation, conduct, and follow-up
- Managed inspection-related communications internally and with Health Authorities
Auditor - Associate Director, Clinical Trials and Safety, Global Quality
Bristol-Myers Squibb
12.2005 - 06.2020
- Conducted internal system/process audits, vendor audits, clinical investigator site audits, and for-cause audits in Europe, Middle-East, Asia, and Africa
- Prepared audit reports, coordinated acceptable CAPA plans, and maintained audit database
- Prepared, led, and followed-up GCP and GCP/GVP regulatory inspections at sponsor affiliates, vendors, and clinical investigator sites worldwide
- Acted as Global Project Coordinator for multiple projects in immunology, responsible for project/study audit plans, risk assessments, and risk-based audit planning globally
- Led or co-led compliance investigations and participated in departmental and global process improvement initiatives
- Participated in Regulatory Intelligence Network (RIN) Teams to ensure compliance with new or revised regulatory policies
- Reviewed and provided input on standard operating procedures and supportive materials
- Provided training, mentoring, and coaching for new and junior staff
- Acted as global Subject Matter Expert and provided consultancy internally to QA team and clinical study teams
- Designed and provided global training sessions on Corrective and Preventive Action Plans (CAPA)
- Provided advice and counsel concerning GCP regulatory requirements to clinical study teams
Protocol Manager (outsourced by SGS - Medisearch Int)
Medisearch Int. (SGS Life Sciences)
02.2005 - 11.2005
- Coordinated a global mega trial in Europe (phase III event-driven study in cardiology “CHARISMA” with 15,600 subjects)
Health Outcomes Researcher (outsourced by SGS - Medisearch Int)
Medisearch Int. (SGS Life Sciences)
09.2003 - 01.2005
- Designed and wrote scientific reports, publications, and posters related to quality of life in CNS and Allergy
Clinical Trial Leader (outsourced by SGS - Medisearch Int)
Medisearch Int. (SGS Life Sciences)
01.2003 - 08.2003
- Coordinated the clinical trial team (phase II international trials in HIV)
Senior Clinical Research Associate
Medisearch International
06.2000 - 12.2002
- Set up, monitored, and followed up phase II trials in HIV and dermatology (Belgium, the Netherlands, Germany, Poland, and Switzerland) and phase I trials in HIV (Belgium)
Data Reviewer and Clinical Research Associate
Medisearch International
03.2000 - 06.2000
- Performed co-monitoring visits of trials in dermatology and HIV and data review activities
Graduate Research Assistant and PhD student
University of Antwerp (UIA)
02.1996 - 02.2000
- Studied the impact of elevated CO2 on physiology and growth of Scots pine (within ECOCRAFT network: "Research of the Likely Impact of Rising CO2 and Temperature on European Forests", supported by European Commission Environment R&D Programme)
- Published 15 peer-reviewed scientific publications/books (Hirsch-index 10, 35.97 impact points, RG 20.11)
- Mentored 2 students during their MSc theses
Education
Master Degree - Biology
Jagiellonian University
01.1989 - 05.1994
Ph.D. Degree - Biology
University of Antwerp
01.1996 - 06.2000
Skills
Team Leadership
Critical Thinking
Project Management
Prioritization
Strategic Planning
Regulatory Knowledge
Adaptability
Creativity
Problem Solving
Stamina
Perseverance
Reliability
Certification
Quality Management Systems (ISO 9000:2000/9001:2008) Lead Auditor, 01/01/07
Timeline
Head of Global Clinical Inspection Management, Director
UCB Pharma
12.2023 - 08.2024
Early and Clinical Development Quality Lead, Associate Director
UCB Pharma
07.2023 - 02.2024
Global Inspection Management Lead, Associate Director
UCB Pharma
07.2023 - 11.2023
Across Compound Inspection Readiness Lead, Associate Director
UCB Pharma
06.2022 - 06.2023
Inspection Lead - Associate Director, Clinical Trial Inspection Management, R&D Quality
Bristol-Myers Squibb
07.2020 - 05.2022
Auditor - Associate Director, Clinical Trials and Safety, Global Quality
Bristol-Myers Squibb
12.2005 - 06.2020
Protocol Manager (outsourced by SGS - Medisearch Int)
Medisearch Int. (SGS Life Sciences)
02.2005 - 11.2005
Health Outcomes Researcher (outsourced by SGS - Medisearch Int)
Medisearch Int. (SGS Life Sciences)
09.2003 - 01.2005
Clinical Trial Leader (outsourced by SGS - Medisearch Int)
Medisearch Int. (SGS Life Sciences)
01.2003 - 08.2003
Senior Clinical Research Associate
Medisearch International
06.2000 - 12.2002
Data Reviewer and Clinical Research Associate
Medisearch International
03.2000 - 06.2000
Graduate Research Assistant and PhD student
University of Antwerp (UIA)
02.1996 - 02.2000
Ph.D. Degree - Biology
University of Antwerp
01.1996 - 06.2000
Master Degree - Biology
Jagiellonian University
01.1989 - 05.1994
Quality Management Systems (ISO 9000:2000/9001:2008) Lead Auditor, 01/01/07
Quality Management Systems (ISO 9001:2015 and Annex SL) Lead Auditor, 01/01/18
Registered and certified Lead Auditor under the International Register of Certified Auditors (IRCA)
ISO 31000 Risk Management, 01/01/16
Head of R&D and Pharmacovigilance Inspection Management, Director
UCB Pharma
6 2022 - Current
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