Summary
Overview
Work history
Education
Skills
CHARITY WORK, INTERESTS & LEISURE ACTIVITIES
Affiliations
Timeline
Generic

Nick Rodopoulos

Summary

Bilingual professional fluent in English and Greek, with moderate proficiency in French, honed through a multicultural upbringing in Montreal, Canada. Demonstrates advanced expertise in Microsoft Office Suite and internet applications, ensuring efficient and effective digital communication. Committed to leveraging language skills and technical proficiency to contribute to dynamic, international environments.

Overview

29
29
years of professional experience
12
12
years of post-secondary education

Work history

Head of Regulatory Inspections and Clinical Internal Audits (RICIA)

IQVIA
2024.01 - 2026.04
  • Heading, overseeing & coordinating GCP & PV the QA program in support of customer accounts, functional accounts, for circa 200 audits and 180 inspections.
  • QA quality management system at a regional and/or global level.
  • Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training and staff.

Senior Compliance Manager- Inspection Management

PPD
2022.02 - 2024.01
  • Leadership and consulting regarding regulatory authority inspection preparation/management as well as support to internal PPD staff during investigator site, client facility, and PPD facility inspections.
  • Lead and/or Supports Client/internal teams with regulatory authority inspection responses.
  • Assists client/internal teams in development of regulatory notification letters as needed. Serves as a primary contact for consulting to internal PPD staff on issues of GCP and PV compliance as well as PPD procedural compliance.
  • Plan, conducts, reports and oversee resolution of directed audits.
  • Serve as a primary contact for consulting to internal PPD staff on issues of GCP and PV compliance as well as PPD procedural compliance.

Global GxP QA Manager (head GCP/PV/GLP)

MeiraGTx
2019.04 - 2022.01
  • Heading the QA Department for GCP, GLP and GVP.
  • Create, Develop and Manage QA audit Team and consultants.
  • Create, Develop, Manage the clinical operations audit programme.
  • Assure the compliance of MeiraGTx clinical operations and systems used therein.
  • Operate closely with MeiraGTx clinical operations team and R&D operations to assure effective functionality.
  • Develop and ensure the QMS meets GCP compliance requirements.
  • Lead and Host regulatory inspections supporting clinical operations.
  • Ensure clinical operations are inspection ready.
  • Lead and perform third party audits supporting MeiraGTx clinical operations related to GCP, GPvP, GCLP, and GLP.
  • Responsible for analysis of clinical quality KPI and data to identify potential trends and risks and producing compliance metrics to present to senior leadership.
  • Develop and establish expertise in Gene therapy clinical studies.
  • Operate globally to assure clinical studies are performed to all local regulatory requirements.
  • Operate in alignment with the MeiraGTx QMS lead and other QA teams to assure interfaces are maintained.
  • Operate in alignment with the logistics teams to assure delivery of ATIMP to investigation sites.
  • Provide GCP training to all staff.
  • Maintain an awareness of new regulatory requirements and assure the QMS incorporates these as required in timely fashion.
  • Actively involved in due diligence activities related to new target opportunities, provide expertise in assessment of clinical data from a quality perspective.
  • Provide assistance to QA team at MeiraGTx as required.
  • Reports to Global VP QA (GMP).

Senior GxP Quality Manager (GLP GCP, GVP)

IPSEN BIOPHARMA
2017.01 - 2019.03
  • Reporting to the Director of Global Quality Assurance.
  • Responsible for Global Risk assessment Audit Schedule QA strategy for GPvP, GCP and GLP.
  • Responsible for Oversight of the conduct of the Global Audit Program for GPvP, GCP and GLP.
  • Leading and managing teams of consultants for successful execution of the audit program.
  • Responsible for auditing and Subject Matter Expert for Ipsen’s signature products Dysport and Lanreotide. Point of Contact to provide expertise and knowledge to less experienced auditors, Stakeholders, Business Partners and Ipsen entities on quality and compliance processes/procedures.
  • Planning, conducting and reporting of Ipsen routine and non-routine audits of Pharmacovigilance activities (affiliate Marketing partners, Vendors) Clinical Development activities, data, internal facilities and R&D processes in GxP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/vendor audits as defined by the scope. Responsible for producing compliance metrics to present to leadership.
  • In cooperation with the audited functions, advises and support in devising and executing remediation actions (CAPAs) to ensure compliance to regulatory and Global Quality expectations and requirements. Approves CAPAs and regularly reviews progress and continue to give ongoing support in all compliance matters.
  • Contributes in the continuous improvement and maintenance of a global GxP compliance platform for reporting, reviewing and trending Global Quality Audit KPIs.
  • Coordinates the development/enhancement of a risk-based audit tool for prioritization of GxP audit activities.
  • Advises, guides and supports sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections) covering inspection preparations, execution, preparation of responses to health authorities and inspection follow-up as well as for key customer audits.
  • Host and Participate in regulatory inspections in core and supporting roles. Assists with the preparation and delivery of training materials. Advises and contributes to coaching. Completes training requirements in a timely manner to ensure inspection readiness at all times.
  • Coordinates the development/enhancement of a risk-based tool for prioritization of GxP inspection readiness activities.

Senior QA Manager

ZIGZAG ASSOSIATES (Quality Assurance Consultancy)
2012.09 - 2016.12
  • Successful delivery of consultancy services and auditing in GPvP, GCP, GCLP, and GLP.
  • GPvP include: LOC audits (almost all European countries including the entire EU-North America (including US and Canada-Asia including Middle East and Far East) System audits (including, Case Management, Risk Management, Aggregate reports, PSMF), Vendor Audits and Marketing Partner audits.
  • GCP include: LOC audits, Site audits (various indications), system audits (including Data Management, Statistics).
  • GLP audits include: Clinical Laboratory Vendor audits (GCLP), Pre-Clinical Vendor audits, Over 300 internal pre-clinical Study plan audits (Protocol, Protocol amendments, Critical Phases, Study reports etc.) and Process audits of various areas (Toxicology, Bioanalysis, Drug Metabolism, In vitro Metabolism, Environmental Metabolism, Physical Chemistry, Pharmacology, Pathology, Histology etc.)
  • Planning, conducting, reporting and following up contracted audits within agreed budget and timelines.
  • Providing management services on contracted client audit programs, overseeing activities delegated to internal auditors and delegated sub-contracting consultants.
  • Assisting in the management, preparation and facilitation of client audits and hosting regulatory inspections and working with responsible parties to prepare CAPA plans as applicable.
  • Providing strategic advice to clients on Quality Management System (“QMS”) development and change.
  • Providing a consultancy service for GCP, GPvP GLP, GCLP, and/or regulations.
  • Developing and delivering training programmes and/or materials.
  • Practiced in the management of Corrective Actions and Preventative Actions (“CAPAs”), associated plans and metrics.
  • Skilled in the preparation and hosting of regulatory inspections.
  • Procedure development and improvement, and training provision.
  • Broad knowledge of regulatory and related statutory requirements including but to limited to EMA, FDA, 21 CFR Part 11, Legal Hold, Data Privacy and Data Protection.

Senior Specialist QA Auditor (GPvP-GCP)

JOHNSON & JOHNSON
2009.06 - 2012.08
  • Planning, conducting and reporting of system-based audits of the Clinical activities of Clinical & R&D as well as, safety reporting and Pharmacovigilance activities of J&J PRD Drug Safety and Surveillance, the J&J Operating Companies and their business partners.
  • Issuing reports of audit findings, and effectively communicate these findings and track corrective action plans through implementation and verification.
  • Conduct the critical review of documents, procedures, and facilities to ensure accuracy for acceptance by International Regulatory Agencies (such as EMEA, FDA).
  • Serve as on-site consultant to Clinical R&D, the Drug Safety and Surveillance Regional Centre staff and as a regional resource to the J&J Operating Companies in Europe.
  • Monitoring new regulatory legislation or guidelines, which have direct impact on Pharmacovigilance and clinical regulatory compliance function.
  • Assisting the facilitation and hosting of inspections by regulatory authorities for Pharmacovigilance and Clinical and working with responsible parties to prepare CAPA plans as applicable.
  • Supporting Licensing and Acquisition GSQA Due Diligence assessments.
  • Super-user for Quality Assurance Database system (QAAD).
  • Member of the Observation Metrics and the audit scheduling teams of the Department.

Senior QA Auditor (GCP) Contract Role

ALLERGAN
2008.10 - 2009.05
  • Responsible for the implementation and execution of Quality Assurance, across Europe Africa, Asia & America.
  • Responsible for ensuring compliance in the Marlow office hosting Regulatory inspections.
  • Author or authorship role on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Computer System Validation (CSV) processes.
  • Lead and participate in audits of internal studies, validation, systems, and/or facilities as well as audits of external central vendors and/or investigator sites.
  • Lead and participate in audits of CROs.
  • Act as expert GCP consultant to groups within the ALLERGAN organization.
  • Provide compliance training to Clinical Personnel.

QA Auditor (GCP) Contract Role

PAREXEL
2007.02 - 2008.10
  • Responsible for ensuring compliance the Sheffield office, including all Sheffield client audits and Regulatory inspections.
  • Responsible for developing an audit strategy and conducting a program of clinical site audits across Europe, Africa, Asia & the Americas, which would take up over 50% percent of working time. Furthermore, data management, statistics, central files, Pharmacovigilance, protocols; CRFs final reports were also part of the auditing program.
  • Work independently and as part of the European QA management team.
  • Act as expert GCP consultant to groups within the PAREXEL organization.
  • Train new and existing Quality Assurance personnel by conducting audits internationally.
  • Train and educate research operational staff by the development and presentation of training courses on Quality Assurance and GCP both internally and externally at relevant meetings/conferences.
  • Deputise Management of Quality Assurance within area of specialisation.
  • Plan, assign and co-ordinate the work of the matrix team for area of specialization. Conduct local PAREXEL office audits in agreement with the Director of Quality Assurance and regional QA manager.

QA Manager (GCP) Contract Role

Orion Clinical Services (OCS)
2006.03 - 2007.02
  • Deputise for Head of Quality Assurance as and when required.
  • Ensure Orion’s compliance with Regulatory Requirements by planning, Conducting and reporting audits/ inspections for all activities supporting clinical trials.
  • Responsible for ensuring continual awareness and implementation of any changes in ICH-GCP/FDA requirements and updating departments and relevant documents as necessary.
  • Generate Audit plans and conduct audits as required by contractual obligations, prepare and issue report for each audit conducted. Audit include site audits across Europe, Africa and the Americas, Data management, statistics, central files audits Pharmacovigilance as well as Protocol, CRF and Final report. As we would only conduct contractual audits these were all done on behalf of the sponsor.
  • Facilitate client audits and liaise with the relevant departments to generate a response to any audit findings, with the client requested time frame.

QA Trainer & Quality Systems Auditor (GLP-GCP)

Huntingdon Life Sciences (HLS).
2003.05 - 2006.03
  • Undertake inspections for various studies of GLP, GMP & GCP compliance, including auditing Protocols, Reports & SOPs. Huntingdon runs more than 2000 pre-clinical and clinical trials a year and have been involved to nearly every type of audit.
  • Undertake inspections (or investigations) across the other 35 Departments (nearly 1200 employees at HLS) to ensure or help to apply the best systems (computerised or not) possible for a better-quality service to our customers. Bioanalysis, Drug Metabolism, In vitro Metabolism, PK, Haematology, Microbiology & Toxicology were some of the Departments involved.
  • Responsible for Company GXP Training (i.e. GLP, GCP & GMP). Responsibilities include managing the training and consultation of staff for GXP issues, running and presenting seminars for GXP on site and attending seminars of other companies for GXP.
  • Representing HLS in the Regional Meetings Forum in East Anglia (running under BARQA for pharmaceutical companies in the region) & responsible for organising meetings in the region under which various GXP problems in the region are tackled.
  • Responsible for collecting data from all the studies done at HLS to ensure GXP, and produce a monthly report for management.

Stability Scientist (R&D) Contract Role

GlaxoSmithKline (GSK)
Durham County
2002.08 - 2003.02
  • Based in Durham County. QC tested respiratory drugs for asthma, measuring Particle size, Bulk Assays, Impurities and Dosage. Worked extensively with HPLC & trained on GLP and GMP.

Stability Scientist (R&D) Contract Role

Merck Sharp & Dohme (MSD)
Northumberland
2002.02 - 2002.08
  • Based in Northumberland. QC tested tablets, capsules and ophthalmic solutions, measuring, where applicable, Dissolution, TLC, Assay, Degradation, Moisture, Impurities, pH, Opalescence, Conductivity, Coloration, Osmolarity and Melting points. Used extensively UV and HPLC. Trained on GLP, GMP and Safety.

Research Scientist (R&D) Contract Role

Procter & Gamble (P&G)
2000.09 - 2001.06
  • Worked at the Newcastle Technical Centre (NTC), on developing hydrophobic bleach activators in washing powders.
  • Progressed to be one the company’s experts on perhydrolysis reactions.
  • Gained experience on running & maintaining own laboratory.
  • Member of team that innovated and developed a new PVA film technology that revolutionised washing known as liquitabs.
  • Got involved in Quality Assurance within the company.

Floor Manager

McDonald’s
Newcastle City
1996.11 - 2000.09
  • Worked full time at Newcastle City centre, trained to work hard, fast and to be part of a team as well as lead and instruct one.

Education

MSc - Analytical Chemistry

University of Northumbria at Newcastle
2000.01 - 2001.01

Post Graduate Certificate - Decision Support Systems (DSS)

University of Sunderland
2001.01 -

BSc (Hons) - Chemistry with Biochemistry

University of Northumbria at Newcastle
1995.01 - 1999.01

Foundation Certificate - undefined

University of Northumbria at Newcastle
1994.01 - 1995.01

High School - undefined

4th High School of Nea Smirni Athens Greece
Nea Smirni Athens, Greece
1991.01 - 1994.01

Junior High School - undefined

4th Junior High School of Nea Smirni Athens Greece
Nea Smirni Athens, Greece
1988.01 - 1991.01

Skills

  • Bilingual in English & Greek (born and lived in Montreal Canada by Greek Parents)
  • French to a moderate level (Montreal is a French city in the state of Quebec within Canada)
  • Advanced user of Microsoft Office (Word, Excel, Power Point, and Access) and the Internet

CHARITY WORK, INTERESTS & LEISURE ACTIVITIES

Trustee and Director of board of charity Greek community school at Newcastle (2019-Today)

Affiliations

  • Regional Coordinator for Northern Regional Forum for BARQA now known as RQA (2007-present)
  • Member of BARQA (Membership No: 4616)
  • Member of the Regional meeting Forum of East Anglia (under BARQA)
  • Member of the Anti-Doping Control Team for the Athens 2004 Olympic Games.

Timeline

Head of Regulatory Inspections and Clinical Internal Audits (RICIA)

IQVIA
2024.01 - 2026.04

Senior Compliance Manager- Inspection Management

PPD
2022.02 - 2024.01

Global GxP QA Manager (head GCP/PV/GLP)

MeiraGTx
2019.04 - 2022.01

Senior GxP Quality Manager (GLP GCP, GVP)

IPSEN BIOPHARMA
2017.01 - 2019.03

Senior QA Manager

ZIGZAG ASSOSIATES (Quality Assurance Consultancy)
2012.09 - 2016.12

Senior Specialist QA Auditor (GPvP-GCP)

JOHNSON & JOHNSON
2009.06 - 2012.08

Senior QA Auditor (GCP) Contract Role

ALLERGAN
2008.10 - 2009.05

QA Auditor (GCP) Contract Role

PAREXEL
2007.02 - 2008.10

QA Manager (GCP) Contract Role

Orion Clinical Services (OCS)
2006.03 - 2007.02

QA Trainer & Quality Systems Auditor (GLP-GCP)

Huntingdon Life Sciences (HLS).
2003.05 - 2006.03

Stability Scientist (R&D) Contract Role

GlaxoSmithKline (GSK)
2002.08 - 2003.02

Stability Scientist (R&D) Contract Role

Merck Sharp & Dohme (MSD)
2002.02 - 2002.08

Post Graduate Certificate - Decision Support Systems (DSS)

University of Sunderland
2001.01 -

Research Scientist (R&D) Contract Role

Procter & Gamble (P&G)
2000.09 - 2001.06

MSc - Analytical Chemistry

University of Northumbria at Newcastle
2000.01 - 2001.01

Floor Manager

McDonald’s
1996.11 - 2000.09

BSc (Hons) - Chemistry with Biochemistry

University of Northumbria at Newcastle
1995.01 - 1999.01

Foundation Certificate - undefined

University of Northumbria at Newcastle
1994.01 - 1995.01

High School - undefined

4th High School of Nea Smirni Athens Greece
1991.01 - 1994.01

Junior High School - undefined

4th Junior High School of Nea Smirni Athens Greece
1988.01 - 1991.01
Nick Rodopoulos