Open to opportunities

Vasul Kolyadintsev

@vasulkolyadintsev

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GCP-focused Quality Assurance leader with 12+ years ensuring regulatory compliance and audit readiness.

Ukraine

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What I'm looking for

I seek a senior QA role where I can lead GCP quality programs, ensure audit readiness, mentor teams, and drive continuous improvement in a collaborative, compliance-focused organization.

I am a strategic, results-oriented Quality Assurance leader with over 12 years of progressive experience in GCP environments across pharmaceutical, biotechnology, and clinical research organizations. I build and lead GCP QA programs, drive audit and inspection readiness, and oversee vendor and clinical site compliance aligned with FDA, EMA, and ICH requirements.

In my most recent role as Quality Assurance Manager, I led global QA initiatives for biospecimen collection, managed end-to-end quality events including deviation investigations and CAPA, developed SOPs and compliance dashboards, and supported sponsor audits and regulatory inspections. I have experience implementing QMS processes across standards such as ISO 9001, ISO 15189, and ISO 20387.

I mentor high-performing QA teams, collaborate cross-functionally with clinical operations, regulatory affairs, and IT, and promote a culture of quality and continuous improvement. I am experienced with QMS tools and regulatory frameworks and I am committed to operational excellence from early-phase development through late-stage trials.

Experience

Work history, roles, and key accomplishments

Quality Assurance Manager

Audubon Bioscience

May 2021 - Jun 2025 (4 years 1 month)

Led global GCP quality assurance for biospecimen collection across clinical sites and labs, managing deviations, CAPAs, audits, and regulatory inspection readiness to ensure compliance with FDA/EMA/ICH standards.

GCP)Quality Management CAPA Auditing SOP Development Risk Management ISO 15189 Regulatory Compliance

Medical Expert – QA & Compliance

LLC Doctor Online

Jan 2018 - May 2021 (3 years 4 months)

Supported clinical trial planning, execution and monitoring with telemedicine integration, ensuring compliance with GCP/ICH/GMP and providing medical consultations, data analysis, and staff training.

GCP)Clinical Data Analysis Telemedicine Regulatory Compliance Training SOPs ICH Guidelines

Clinical Verification Doctor

DILA Medical Laboratory

Jun 2016 - Dec 2018 (2 years 6 months)

Organized and oversaw medical verification activities, performed clinical result verification per ISO 15189, led CAPA-driven resolution of deviations and trained staff on data handling and quality standards.

ISO 15189 CAPA Quality Assurance Training Data Validation Cross Functional Collaboration

Education

Degrees, certifications, and relevant coursework

National Medical Academy of Post-Graduate Education Named After P.L. Shupik

Postgraduate study, Clinical Laboratory Diagnostics

2018 - 2022

Postgraduate study in Clinical Laboratory Diagnostics completed between 2018 and 2022, focused on advanced clinical laboratory diagnostic methods and practice.

National Medical Academy of Post-Graduate Education Named After P.L. Shupik

Clinical Residency, Clinical Laboratory Diagnostics

2016 - 2018

Clinical residency in Clinical Laboratory Diagnostics from 2016 to 2018 with supervised practical training in laboratory diagnostics and clinical verification.