Josipa Ljubicic

CEO/GxP Auditor

Josipa Ljubicic
Zagreb, Croatia

Experience

Aug 2023 - Present
2 years 6 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

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)

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