Sergey Muzykantsky

Contract Quality Manager / QA Consultant / Lead GCP Auditor

Sergey Muzykantsky
Barcelona, Spain

Experience

Jan 2024 - Present
2 years 1 month

Contract Quality Manager / QA Consultant / Lead GCP Auditor

MedGxP Consulting SL

  • Provide GCP compliance oversight and quality management support to clinical development teams across Europe.
  • Develop and maintain fit-for-purpose Quality Management Systems (QMS), SOPs, and procedural controls.
  • Identify, assess, and manage quality issues, ensuring timely CAPA implementation.
  • Support sponsor preparation for external audits and global regulatory inspections.
  • Deliver GCP and study-specific training to internal staff and investigators.
  • Conduct GCP audits at clinical sites, including routine and directed investigator site audits, Phase I units, and BE centers.
  • Conduct GCP audits of vendors including CROs, laboratories (bioanalytical and safety), and data management providers.
  • Conduct GCP audits of systems and processes including TMF/PMF, EDC/databases (incl. development phase), safety reporting, and staff qualification records.
  • Conduct GCP audits of study documentation including final study reports, essential documents, and training logs.
Jan 2022 - Jan 2024
2 years 1 month
Barcelona, Spain

Senior GCP Auditor, Global GxP Audit

Novartis Farmaceutika S.A

  • Plan and execute global GCP audits across diverse trial phases and regions.
  • Conduct routine and for-cause investigator site audits to assess compliance and data integrity.
  • Lead system audits of clinical operations processes and quality oversight frameworks.
  • Audit key clinical service providers including full-service CROs, monitoring partners, data management vendors, and central labs.
  • Perform internal audits of country development activities to ensure compliance with Novartis and regulatory standards.
Nov 2019 - Sep 2021
1 year 11 months
Hellerup, Denmark

Associate Director, GCP and PV Regulatory Compliance

Ascendis Pharma A/S

  • Lead development and strategic review of global Quality Management System (QMS) documentation to ensure GCP and PV compliance across studies.
  • Serve as primary GCP/QA advisor to cross-functional study (rare disease) teams by reviewing essential study documents, participating in team meetings, and providing on-demand regulatory guidance.
  • Oversee vendor and site audits performed by external consultants, ensuring quality and consistency in reporting and follow-up.
  • Collaborate with Clinical, Regulatory, and PV departments to align compliance activities across programs.
  • Develop annual and study-specific global audit plans and ensure execution according to timelines and risk levels.
  • Support and host Regulatory Authority inspections (FDA, Danish Medicines Agency) at corporate offices, including preparation of sites and internal teams.
  • Lead CAPA development and follow-up for both internal findings and third-party audits.
  • Mentor and support junior QA staff, ensuring consistent application of regulatory standards.
  • Deliver targeted GCP training to internal teams and investigative sites, including speaking at online investigator meetings.
  • Conduct audits of clinical vendors, investigational sites, and clinical study reports (CSRs) to ensure compliance and data integrity.
Sep 2012 - Dec 2014
2 years 4 months
Saint Petersburg, Russian Federation

Head of Quality Assurance (Contract Role)

Global Clinical Trials LLC

  • Lead QA function, overseeing development, implementation, and continuous improvement of the QMS.
  • Manage full lifecycle of SOPs including creation, version control, approval, periodic review, and archival.
  • Plan and execute internal audits and host external audits to assess GCP compliance and process integrity.
  • Conduct routine, directed, and for-cause investigator site audits to ensure protocol adherence and regulatory alignment.
  • Develop annual audit plans, author audit reports, and lead CAPA discussions to drive sustainable improvements.
  • Design and deliver GCP training programs for new hires and existing staff, ensuring compliance with ICH-GCP and local regulatory requirements.
  • Strengthen inspection readiness and support company-wide audit preparedness.
Sep 2011 - Oct 2019
8 years 2 months
Saint Petersburg, Russian Federation

Independent GCP Consultant / QA Auditor / GCP Trainer

Freelance

  • Provide GCP quality assurance and compliance consulting to small and mid-sized CROs, investigational sites, and SMOs.
  • Support development, implementation, and maintenance of Quality Management Systems (QMS).
  • Conduct mock CRO audits and inspection readiness assessments for sponsors and sites.
  • Deliver tailored GCP training programs to site staff, CRAs, and QA professionals (basic to advanced level).
  • Present at national and international clinical research conferences as a GCP subject matter expert.
  • Conduct auditing experience in clinical operations (investigator site audits, Phase I units, BE centers), vendor oversight (CROs, data management vendors, bioanalytical and central laboratories), and system & process audits (TMF/PMF, database development, safety reporting, staff qualification, final reports).
  • Support regulatory inspection preparation and post-audit CAPA development.
Mar 2010 - Aug 2011
1 year 6 months
Saint Petersburg, Russian Federation

Senior Quality Assurance Auditor

INC Research UK Ltd

  • Conduct comprehensive audits of investigator sites, TMF/PMF files, project databases, safety reporting, and vendor processes to ensure compliance with GCP, internal SOPs, and sponsor commitments.
  • Author audit reports and evaluate responses to ensure effective CAPA implementation.
  • Provide regulatory compliance guidance to cross-functional project teams throughout clinical development.
  • Lead both internal and contracted audits, including planning, execution, and client communication; serve as key point of contact for sponsor audits.
  • Mentor junior auditors, sharing best practices and supporting their development.
  • Support ongoing quality assurance by maintaining audit documentation and contributing to continuous improvement in QA processes.
Jul 2007 - Dec 2009
2 years 6 months
Saint Petersburg, Russian Federation

Compliance Associate

PharmaNet LLC

  • Perform GCP compliance audits of investigator sites, vendors, study databases, and clinical study reports across Russia, Ukraine, EU (incl. UK, Germany, Spain, Italy, and others), and Australia.
  • Execute internal process audits leading to improved adherence to SOPs across functional departments.
  • Develop and deliver targeted GCP training sessions for investigators at multiple clinical trial sites.
Jan 2006 - Jun 2007
1 year 6 months
Saint Petersburg, Russian Federation

Clinical Research Associate II (CRA II)

PharmaNet LLC

  • Monitor three multicenter cardiology studies across 20 sites (300 patients), conducting all monitoring visit types with 40–50% travel.
  • Identify and recruit investigational sites, manage site budget negotiations.
  • Mentor junior CRAs in monitoring procedures, sponsor communication, and issue resolution.
Oct 2004 - Jan 2006
1 year 4 months
Moscow, Russian Federation

Clinical Research Associate (CRA) - Psychiatry

Janssen Pharmaceutica NV

  • Monitor up to 12 clinical studies across 25 investigational sites, conducting all visit types (pre-study, initiation, routine, and close-out).
  • Manage regulatory submissions and investigator documentation in compliance with local and international requirements.
  • Deliver training and day-to-day support to site staff and internal clinical personnel to ensure protocol adherence and data integrity.
Sep 2002 - Sep 2004
2 years 1 month
Saint Petersburg, Russian Federation

Clinical Research Associate (CRA) – Oncology

PSI Pharma Support Intl.

  • Oversee full monitoring lifecycle at investigational sites, including pre-study, initiation, routine, and close-out visits.
  • Deliver training to clinical site personnel to ensure compliance with protocol and regulatory requirements.
  • Mentor junior CRAs on monitoring practices, internal workflows, and query resolution strategies.
Jan 2001 - Sep 2002
1 year 9 months
Saint Petersburg, Russian Federation

Ophthalmologist

Catty Sark Optic Shops

Sep 1998 - Sep 2000
2 years 1 month
Murmansk, Russian Federation

Ophthalmologist

City Outpatient Clinic

Summary

Quality Assurance professional with over 23 years of experience in the pharmaceutical, biotechnology, and clinical research sectors. Over the past 18 years, conducted more than 380 Good Clinical Practice (GCP) compliance audits across the EU, US, UK, Africa, and Australia. Experienced in preparing for and hosting regulatory authority inspections in both the US and EU. Certified GCP Auditor. Serves as a QA consultant to pharmaceutical and biotechnological companies as well as contract research organizations, providing comprehensive support for clinical trial quality oversight, QMS development and review, GCP audits, inspection readiness, and personnel training. MD background enables effective communication with clinicians and strong protocol comprehension.

Skills

  • Gcp Auditing (Sponsor, Cro, Site, Tmf, System)

  • Capa Management And Qms Oversight

  • Inspection Readiness And Regulatory Compliance

  • Clinical Trial Oversight (Phase I - Iv)

  • Rbqm & Qa Strategy

  • Sop Development And Gcp Training

  • Medidata Rave

  • Veeva Vault

  • Oracle Inform

  • Bioclinica Express

  • Df/net Research Idatafax

  • Openclinica Edc

Languages

Russian
Native
English
Advanced
Danish
Elementary
Spanish
Elementary

Education

Sep 2000 - Aug 2002

St. Petersburg Medical Academy of Postgraduate Education

Residency in Ophthalmology · Ophthalmology · Saint Petersburg, Russian Federation

Sep 1999 - Dec 1999

St. Petersburg Medical Academy of Postgraduate Education

Advanced Training in Ophthalmology · Ophthalmology · Saint Petersburg, Russian Federation

Sep 1997 - Aug 1998

Murmansk City Hospital

Internship in General Surgery · General Surgery · Murmansk, Russian Federation

...and 2 more

Certifications & licenses

Certified GCP Auditor

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