Josipa Ljubicic-CEO/GxP Auditor
Check rate
Experience
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
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)
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
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
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
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
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
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
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
CFO Assistant
Johnson & Johnson S.E.Ltd.
- Maintaining travel requests and working on cost analysis
- Managing travel expenses and archive management
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
Drug Distributor
Phoenix Pharmacia Ltd.
- Communicating daily with local pharmacies
- Coordinating drug shipments and controlling drug packages
- Maintaining drug distribution
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
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.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Finance, Operations, Research and Development, Strategy, and Accounting.
Languages
Education
University of Rijeka, Faculty of Biotechnology and Drug Development
PhD, Medicinal Chemistry · Medicinal Chemistry · Rijeka, Croatia
University of Zagreb, Faculty of Chemical Engineering and Technology
Master of Science, Chemical Engineering and Technology · Chemical Engineering and Technology · Zagreb, Croatia
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
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Josipa is based in Zagreb, Croatia.
Josipa speaks the following languages: Croatian (Native), Bosnian (Advanced), English (Advanced), Serbian (Advanced), German (Intermediate), Italian (Elementary), Slovenian (Elementary).
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.
Based on recent experience, Josipa would be well-suited for roles such as: CEO/GxP Auditor, QA Director/GxP Auditor, Senior QA Auditor.
Josipa's most recent position is CEO/GxP Auditor at Proqlea Ltd..
In recent years, Josipa has worked for Proqlea Ltd. and ICON Clinical Research Ltd..
Josipa is most experienced in industries like Pharmaceutical, Healthcare, and Transportation.
Josipa is most experienced in business areas like Quality Assurance, Operations, and Finance. Josipa also has some experience in Research and Development, Strategy, and Accounting.
Josipa has recently worked in industries like Pharmaceutical and Healthcare.
Josipa has recently worked in business areas like Quality Assurance, Research and Development, and Strategy.
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.
Josipa has 7 certificates. Among them, these include: GLP And GcLP Certificate, GMP Auditor Certification, and Good Clinical Practice Certificate.
The availability of Josipa needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 25 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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