Aleksandr Stapel
Global GCP Auditor
Mainz
Summary
Certified ISO 9001 Auditor and Member of Research Quality Association (RQA) with 10+ years of experience in clinical trials. Highly skilled in GxP regulations and guidelines (EMA, FDA etc.), risk assessment and CAPA management. Grew from the position of Assistant in Clinical Operations
to a Senior CRA in PAREXEL CRO and, eventually, a QA Auditor of clinical trials and pharmacovigilance in BIOCAD. This extensive professional experience of 50+ trials in various roles gave me a uniquely broad perspective on the clinical trial process. Seeking to leverage excellent
organizational and collaborative skills to provide Quality advice to Clinical teams.
Overview
5
5
years of professional experience
3
3
Certifications
3
3
Languages
Work History
Global GCP Auditor
Boehringer Ingelheim
6 2022 - Current
- Conducting remote and onsite audits (investigator sites, third parties, systems, for-cause audits) globally
- Overseeing the External Auditors and manage cross-functional interaction
- Drafting and evaluating audit reports in Trackwise and MS Office
- Evaluation of CAPA process
- Assuring inspection readiness for clinical projects in terms of GxP regulation, EMA and FDA standards
- Risk analysis, evaluation and review for study projects
- Collaborating with vendor managers, compliance managers and CAPA team in terms of CAPA execution.
- Conducted risk assessments to determine areas requiring increased focus during subsequent audits
- Onboard new colleagues in QA group
Senior Clinical Site Manager
PAREXEL International
5 2013 - 4 2019
- Grew from the position of Assistant in Clinical Operations to a Senior CRA in PAREXEL CRO due to successful trial monitoring, taking on additional clinical trial projects and exceptional performance results
- Conducted 5+ monthly monitoring visits including SIV, MV, and Close Out Visit
- Acted as clinical sites' main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial
- Oversaw the trial at designated sites ensuring the rights and well-being of human subjects were protected, quality and integrity of the reported data and the conduct of the trial was in compliance with the currently approved protocols/amendments, with ICH-GCP and with the applicable regulatory requirements.
QA Auditor of Clinical and Pharmacovigilance Department
BIOCAD JSC
04.2019 - 06.2022
- Owned the full spectrum of QA auditing functions: developing a yearly audit plan for the QA department based on risk-averse methodology, providing recommendations to facilitate quality improvements, evaluation of audit findings, full CAPA management process, reporting to operations staff, management, and customers
- Conducted 50+ onsite and remote audits across Russia, Belarus, China, Ireland, including Clinical trial sites (Phase I-III), TMF, Clinical Laboratory, IP Depots, CRO qualification, First-in-human units, Service providers, Archives, Internal QMS audits, Pharmacovigilance system audits, Study project audits
- Conducted 30+ audits of clinical sites, vendors, subcontractors, third-party trial participants, and internal company departments (Pharmacovigilance, Clinical development, Data management etc) as a Lead auditor in accordance with the QMDs, GxP guidelines, and local regulations
- Developed 4 internal QA SOPs resulting in a more effective and simplified audit reviewing procedures
- Mentored and onboarded 10+ CD&O employees in the area of QA.
Education
Conducting clinical trials in accordance with GCP rules -
The Pavlov First Saint Petersburg State Medical University
Master degree in Pharmaceutical Science - undefined
Saint Petersburg State Chemical and Pharmaceutical University
Skills
CAPA management
Process evaluations
GxP Auditing
Risk assessment
Root Cause Analysis
SOP Adherence
Investigator site audit
Vendor management & audit
Process audit
Pharmacovigilance auditing
Risk mitigation strategies
SOP development & maintenance
ICH-GCP
Teamwork
Employee training
Issue Resolution
Trackwise
MS Office
Report Writing
Audit Coordination
Internal Controls
Certification
Quality Management Auditor, 03/2023,
Timeline
QA Auditor of Clinical and Pharmacovigilance Department
BIOCAD JSC
04.2019 - 06.2022
Global GCP Auditor
Boehringer Ingelheim
6 2022 - Current
Senior Clinical Site Manager
PAREXEL International
5 2013 - 4 2019
Conducting clinical trials in accordance with GCP rules -
The Pavlov First Saint Petersburg State Medical University
Master degree in Pharmaceutical Science - undefined
Saint Petersburg State Chemical and Pharmaceutical University
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