Sergey Muzykantsky - Contract Quality Manager / QA Consultant / Lead GCP Auditor

Q: Where is Sergey based?

Sergey is based in Barcelona, Spain .

Q: What languages does Sergey speak?

Sergey speaks the following languages: Russian (Native), English (Advanced), Danish (Elementary), Spanish (Elementary) .

Q: How many years of experience does Sergey have?

Sergey has at least 27 years of experience. During this time, Sergey has worked in at least 11 different roles and for 11 different companies . The average length of individual experience is 2 years and 3 months . Note that Sergey may not have shared all experience and actually has more experience.

Q: What is Sergey's latest experience?

Sergey's most recent position is Contract Quality Manager / QA Consultant / Lead GCP Auditor at MedGxP Consulting SL .

Q: What companies has Sergey worked for in recent years?

In recent years, Sergey has worked for MedGxP Consulting SL , Novartis Farmaceutika S.A , and Ascendis Pharma A/S .

Q: Which industries is Sergey most experienced in?

Sergey is most experienced in industries like Pharmaceutical , Biotechnology , and Healthcare . Sergey also has some experience in Professional Services .

Q: Which business areas is Sergey most experienced in?

Sergey is most experienced in business areas like Quality Assurance (QA) , Research and Development (R&D) , and Audit .

Q: Which industries has Sergey worked in recently?

Sergey has recently worked in industries like Pharmaceutical , Biotechnology , and Professional Services .

Q: Which business areas has Sergey worked in recently?

Sergey has recently worked in business areas like Quality Assurance (QA) , Research and Development (R&D) , and Audit .

Recommended expert

Barcelona, Spain

Experience

Jan 2024 - Present

2 years 2 months

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

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (23 years), Biotechnology (12 years), Healthcare (3.5 years), and Professional Services (2 years).

Pharmaceutical

Biotechnology

Healthcare

Professional Services

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (19.5 years), Research and Development (15 years), and Audit (2 years).

Quality Assurance

Research and Development

Audit

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

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Sergey based?

Sergey is based in Barcelona, Spain.

What languages does Sergey speak?

Sergey speaks the following languages: Russian (Native), English (Advanced), Danish (Elementary), Spanish (Elementary).

How many years of experience does Sergey have?

Sergey has at least 27 years of experience. During this time, Sergey has worked in at least 11 different roles and for 11 different companies. The average length of individual experience is 2 years and 3 months. Note that Sergey may not have shared all experience and actually has more experience.

What roles would Sergey be best suited for?

Based on recent experience, Sergey would be well-suited for roles such as: Contract Quality Manager / QA Consultant / Lead GCP Auditor, Senior GCP Auditor, Global GxP Audit, Associate Director, GCP and PV Regulatory Compliance.

What is Sergey's latest experience?

Sergey's most recent position is Contract Quality Manager / QA Consultant / Lead GCP Auditor at MedGxP Consulting SL.

What companies has Sergey worked for in recent years?

In recent years, Sergey has worked for MedGxP Consulting SL, Novartis Farmaceutika S.A, and Ascendis Pharma A/S.

Which industries is Sergey most experienced in?

Sergey is most experienced in industries like Pharmaceutical, Biotechnology, and Healthcare. Sergey also has some experience in Professional Services.

Which business areas is Sergey most experienced in?

Sergey is most experienced in business areas like Quality Assurance (QA), Research and Development (R&D), and Audit.

Which industries has Sergey worked in recently?

Sergey has recently worked in industries like Pharmaceutical, Biotechnology, and Professional Services.

Which business areas has Sergey worked in recently?

Sergey has recently worked in business areas like Quality Assurance (QA), Research and Development (R&D), and Audit.

What is Sergey's education?

Sergey holds a Doctorate in Medicine from Petrozavodsk State University, Medical Department, a Bachelor in Ophthalmology from St. Petersburg Medical Academy of Postgraduate Education and a Bachelor in Ophthalmology from Murmansk City Hospital.

Does Sergey have any certificates?

Sergey has 1 certificate: Certified GCP Auditor.

What is the availability of Sergey?

Sergey is immediately available part-time for suitable projects.

What is the rate of Sergey?

Sergey's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.