Josipa Ljubicic - CEO/GxP Auditor

Q: Where is Josipa based?

Josipa is based in Zagreb, Croatia .

Q: What languages does Josipa speak?

Josipa speaks the following languages: Croatian (Native), Bosnian (Advanced), English (Advanced), Serbian (Advanced), German (Intermediate), Italian (Elementary), Slovenian (Elementary) .

Q: How many years of experience does Josipa have?

Josipa has at least 21 years of experience. During this time, Josipa has worked in at least 13 different roles and for 11 different companies . The average length of individual experience is 2 years and 6 months . Note that Josipa may not have shared all experience and actually has more experience.

Q: What is Josipa's latest experience?

Josipa's most recent position is CEO/GxP Auditor at Proqlea Ltd. .

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

In recent years, Josipa has worked for Proqlea Ltd. and ICON Clinical Research Ltd. .

Q: Which industries is Josipa most experienced in?

Josipa is most experienced in industries like Pharmaceutical , Healthcare , and Transportation .

Q: Which business areas is Josipa most experienced in?

Josipa is most experienced in business areas like Quality Assurance , Operations , and Finance . Josipa also has some experience in Research and Development , Accounting , and Logistics .

Q: Which industries has Josipa worked in recently?

Josipa has recently worked in industries like Pharmaceutical and Healthcare .

Q: Which business areas has Josipa worked in recently?

Josipa has recently worked in business areas like Quality Assurance , Research and Development , and Strategy .

Recommended expert

Zagreb, Croatia

Experience

Aug 2023 - Present

2 years 8 months

CEO/GxP Auditor

Proqlea Ltd.

Passionate leadership, expertise and successful management in the field of clinical trials with goal to enhance the healthcare industry through innovative solutions, effective team leadership, and achieving high-quality standards in clinical trials
Guiding the company through strategic visions and achieving goals in the field of clinical trials
Developing and implementing innovative approaches to expedite the approval and market launch of new products
Efficiently managing teams of researchers, experts, and collaborators to achieve optimal results in all stages of trials
Steering the company towards strategic partnerships with pharmaceutical companies, academic institutions, and regulatory bodies
Overseeing central lab services to provide comprehensive support to clients utilizing our CRO services, addressing confounding factors and ensuring accurate, reliable results
Managing the portfolio of clinical trials from initial development phase to completion with focus on efficiency and ethics
Establishing collaboration with key stakeholders to secure support and resources for research
Monitoring regulatory guidelines and ensuring compliance with the latest standards in the clinical trials industry
Skills:
Strategic leadership and planning
Multitasking in different areas
Budgeting
Exceptional analytical and problem-solving skills
Efficient time and resource management
Developing and maintaining partnerships with key stakeholders
Deep understanding of regulatory guidelines and ethical principles in clinical trials
Expertise in central lab services to mitigate confounding factors for clients utilizing our CRO services

Sep 2021 - Aug 2023

2 years

QA Director/GxP Auditor

Proqlea Ltd.

Business development and daily communication with clients
People management, providing initial and ongoing trainings
Operating as contracted outsourced COO and Global QA Director/Manager role for mid-size CROs or sponsor companies
Development of QMS from the beginning and preparation for ISO certification
SOP writing according to local and EU/FDA regulation and ISO 9001, 17025, 15189, 14001, 27001
Defining job descriptions and matrix for different roles
Ensuring audit/inspection readiness and QMS compliance with all GxPs (GCP, GMP, GVP) and regulatory requirements (EMA and FDA)
Internal QMS auditing (PV, RA, CT department) and external QMS auditing (vendor audits, GCP, GVP, GMP audits)
Defining CAPAs and tracking implementation
Vendor/client assessment (qualification audits) and QC documentation
Hosting regulatory authority inspections (FDA, EMA and MHRA) and various audits (clients, sponsors)

Oct 2019 - Sep 2021

2 years

Senior QA Auditor

ICON Clinical Research Ltd.

Conducting internal and vendor audits, regulatory/sponsor inspection defense, case management and CAPA management
Performing project audits, process audits (TMF, monitoring, protocol assessment, PD and AI audit, etc.) and on-site audits
Assisting with implementation and maintenance of an effective Quality Management System / Quality Assurance program
Performing departmental and ICON staff training regarding ICON's quality system, Q&C tasks and processes, applicable standards and regulations
Mentoring new or developing Q&C staff as assigned

Apr 2018 - Oct 2019

1 year 7 months

Head of QA, GCP Auditor

Marti Farm Ltd.

People management and providing initial and ongoing trainings
Supervising development and implementation of annual employee education
Defining job descriptions and matrix for different roles
Writing SOPs/WIs according to local and EU regulation and ISO 9001
Planning risk management and managing codebook
Developing quality plan and writing quality annual report
Managing deviation and change control
Supervising controlled and uncontrolled copies
Preparing annual revision plan for SOPs/WIs and annual internal audit plan
Audit preparation (QMS, GCP, GDP, GVP) and regulatory inspection preparation
Internal QMS auditing (PV, RA, CT department) and external QMS auditing (outsource service, vendor audits)
Defining CAPAs and tracking implementation
Vendor/client assessment (pre-audit) and QC documentation

Sep 2017 - Jun 2018

10 months

Clinical Trial Lead

Marti Farm Ltd.

SSU and RA submissions and development of essential study documents
Supervising start-up activities and feasibility questionnaire workflow
Developing timelines and supervising monitoring plan and query resolution
Controlling dossier submissions and document management (PMF, e-PMF, OSF)
Preparing and participating in project/site level audits, inspections and corrective action plans
Supervising CAPA implementation
Contract negotiation and budgeting, preparation and approval of BTR/invoices and financial plans
Monitoring budget and cost control
Clinical Trial Agreement supervision with legal and financial department on site
Maintaining SAE report flow and QA assessment of site visits
Providing project specific trainings to study personnel and project team support

Apr 2017 - Sep 2017

6 months

Clinical Trial Specialist

Marti Farm Ltd.

Participating in business meetings with partners and clients
Reviewing documentation and RA/EC submissions including initial submissions and amendments
Managing study related contracts
Monitoring, back-up monitoring and co-monitoring on sites
Coordinating site visits (SSV, SIV, RMV, COV and unscheduled visits)
Preparing monitoring reports and site visit letters
Training clinical investigators and hosting sponsor meetings
Preparing for site audits and inspections and resolving queries

Jun 2015 - Mar 2017

1 year 10 months

Clinical Trial Assistant

PSI CRO Ltd.

Providing administrative project support to PMs, CRAs and PCs in phase I-IV trials
Communicating with sites and vendors and preparing agendas and meeting minutes
Supporting audit preparation and follow-ups
Conducting non-medical training of site staff
Processing and filing study documentation
Processing financial and contractual documentation
Assisting with procurement of regulatory documents
Co-monitoring and office management
Preparing clinical trial submission requests to EC/CA/IRB/LEC
Reporting safety (CIOMS reports, DSUR, SUSAR line listing reports, annual reports) to regulatory bodies

Aug 2014 - Jun 2015

11 months

Regulatory Affairs Specialist

Genera Ltd.

Conducting regulatory activities locally and internationally covering 19 countries of Southeast Europe, Switzerland and South America
Preparing and submitting registration dossiers for medicinal products
Submitting variations and renewal applications for medicinal products
Working in accordance with CRO and EU regulations for medicinal products
Cooperating with Ministry of Agriculture, Ministry of Health and all agencies involved in veterinary product registration
Preparing periodic reports (PSUR) and labels and PILs for disinfectants
Cooperating with marketing department on creative mockup redesign

Jun 2013 - Jun 2014

1 year 1 month

Regulatory Affairs Specialist

Pliva Croatia (Teva) Ltd.

Conducting regulatory activities for drug registration (initial submissions, renewals, withdrawals, variations) locally and internationally
Managing variation submission processes (IA I, IA II, IB, II)
Cooperating daily with CEC (Halmed), Ministry of Health and international agencies (EMEA, MHRA)
Preparing dossiers in NeeS and eCTD structure and collecting documentation for all modules
Reviewing SmPC, PIL and mockups
Cooperating with QC, non-medical, medical departments and laboratories
Following up on product life cycle

Jan 2007 - Dec 2009

3 years

CFO Assistant

Johnson & Johnson S.E.Ltd.

Maintaining travel requests and working on cost analysis
Managing travel expenses and archive management

Jan 2005 - Dec 2006

2 years

Analytical Laboratory Technician

GlaxoSmithKline Ltd.

Working in drug production and selecting and controlling harmful chemical waste disposal
Performing quality control of database of all chemicals in laboratories

Jan 2004 - Dec 2005

2 years

Drug Distributor

Phoenix Pharmacia Ltd.

Communicating daily with local pharmacies
Coordinating drug shipments and controlling drug packages
Maintaining drug distribution

Jan 2003 - Dec 2004

2 years

Administrator

Orbico Ltd.

Preparing product declarations, labeling and packaging for distribution
Cleaning and maintaining facility
Managing product distribution administration
Working in finance department including invoice and archive management

Jan 2002 - Dec 2003

2 years

Pharmaceutical Technician

Pharmacy Imotski Ltd.

Distributing drugs and communicating with patients
Preparing galenic products
Performing daily drug control and quality control of drug orders

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical, Healthcare, and Transportation.

Pharmaceutical

Healthcare

Transportation

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Finance, Operations, Research and Development, Accounting, and Logistics.

Quality Assurance

Finance

Operations

Research and Development

Accounting

Logistics

Languages

Croatian

Native

Bosnian

Advanced

English

Advanced

Serbian

Advanced

German

Intermediate

...and 2 more

Education

Oct 2019 - Jun 2024

University of Rijeka, Faculty of Biotechnology and Drug Development

PhD, Medicinal Chemistry · Medicinal Chemistry · Rijeka, Croatia

Oct 2007 - Jun 2012

University of Zagreb, Faculty of Chemical Engineering and Technology

Master of Science, Chemical Engineering and Technology · Chemical Engineering and Technology · Zagreb, Croatia

Oct 1998 - Jun 2002

Health high school Zagreb

Graduation, Pharmaceutical Technician · Pharmaceutical Technician · Zagreb, Croatia

Certifications & licenses

GLP And GcLP Certificate

Global Pharma QA Ltd.

GMP Auditor Certification

GxP Synapse, Zagreb, Croatia

Good Clinical Practice Certificate

National Institute on Drug Abuse and Clinical Trials Network

GCP Auditor Certification

NBScience, International Society of GxP Standards (France); London

PV Audit Preparation Certificate

Supera Kvaliteta

QMS Auditor

Supera Kvaliteta

GMP Certificate

Teva (Pliva Hrvatska)

Statistics

Experience

Total positions 14

Experience in Pharmaceutical 20.5 y

Avg length 1 y 8 m

Longest experience 2 y 11 m

Expertise

Recent roles CEO/GxP Auditor, QA Director/GxP Auditor, Senior QA Auditor

Main industries Pharmaceutical, Healthcare, Transportation

Main business areas Quality Assurance, Finance, Operations

Qualifications

Highest degree Doctorate

Certifications earned 7

Profile

Created

January 2026

Last Update

February 2026

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Frequently asked questions

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

Where is Josipa based?

Josipa is based in Zagreb, Croatia.

What languages does Josipa speak?

Josipa speaks the following languages: Croatian (Native), Bosnian (Advanced), English (Advanced), Serbian (Advanced), German (Intermediate), Italian (Elementary), Slovenian (Elementary).

How many years of experience does Josipa have?

Josipa has at least 21 years of experience. During this time, Josipa has worked in at least 13 different roles and for 11 different companies. The average length of individual experience is 2 years and 6 months. Note that Josipa may not have shared all experience and actually has more experience.

What roles would Josipa be best suited for?

Based on recent experience, Josipa would be well-suited for roles such as: CEO/GxP Auditor, QA Director/GxP Auditor, Senior QA Auditor.

What is Josipa's latest experience?

Josipa's most recent position is CEO/GxP Auditor at Proqlea Ltd..

What companies has Josipa worked for in recent years?

In recent years, Josipa has worked for Proqlea Ltd. and ICON Clinical Research Ltd..

Which industries is Josipa most experienced in?

Josipa is most experienced in industries like Pharmaceutical, Healthcare, and Transportation.

Which business areas is Josipa most experienced in?

Josipa is most experienced in business areas like Quality Assurance, Operations, and Finance. Josipa also has some experience in Research and Development, Accounting, and Logistics.

Which industries has Josipa worked in recently?

Josipa has recently worked in industries like Pharmaceutical and Healthcare.

Which business areas has Josipa worked in recently?

Josipa has recently worked in business areas like Quality Assurance, Research and Development, and Strategy.

What is Josipa's education?

Josipa holds a Doctorate in Medicinal Chemistry from University of Rijeka, Faculty of Biotechnology and Drug Development and a Master in Chemical Engineering and Technology from University of Zagreb, Faculty of Chemical Engineering and Technology.

Does Josipa have any certificates?

Josipa has 7 certificates. Among them, these include: GLP And GcLP Certificate, GMP Auditor Certification, and Good Clinical Practice Certificate.

What is the availability of Josipa?

Josipa is immediately available full-time for suitable projects.

What is the rate of Josipa?

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