Georgina Dimovski
Thornbury,Australia
Summary
Quality-focused leader skilled in optimizing GxP operations within regulated environments. Led cross-functional teams to implement global compliance systems and enhance operational efficiency through lean initiatives. Strong communicator and problem-solver, driving successful outcomes in fast-paced settings while fostering a culture of quality and continuous improvement.
Overview
24
24
years of professional experience
Work History
Associate Director Global R&D Quality
CSL
Parkville, Australia
06.2023 - Current
- Provided global QA leadership to harmonize quality systems across global manufacturing and testing network, strengthening organizational compliance through collaboration with QA teams and business stakeholders.
- Establish and implement scalable quality systems and GMP‑aligned processes (change control, deviations, CAPA, documentation lifecycle, training, metrics, audit and supplier management), ensuring compliance and data integrity.
- Lead internal and external audits, implement global risk‑based audit and inspection readiness programs, delivering improved regulatory outcomes and reduced preparation efforts.
- Quality oversight of 140+ CROs and contract laboratories for compliance with major regulatory bodies.
- Led cross-functional initiatives that resulted in faster CAPA closeout times and improved regulatory inspection outcomes.
- Built and developed high-performing QA teams through capability development, cross-training frameworks, and coaching, fostering a culture of compliance.
- Translated global frameworks into effective local quality processes supporting site setup and readiness.
Snr Manager Vendor Oversight Global R&D Quality
CSL
Parkville, Australia
10.2019 - 06.2023
- Provided strategic quality oversight for global R&D service providers, including vendor assessment and compliance monitoring.
- Led inspections and interactions with regulators to ensure adherence to TGA, PIC/S, and international standards.
- Applied ICH, FDA, EMA, TGA, and PIC/S knowledge in evaluating vendor controls and compliance decisions.
- Oversaw clinical development vendors, ensuring alignment with quality expectations for vaccines and biologics.
- Developed global risk-based oversight program that strengthened quality management of R&D service providers.
- Managed quality audits of all GxP-relevant service providers engaged by R&D globally.
- Established performance indicators for vendors and escalated issues through governance to ensure compliance.
- Earned recognition for implementing quality improvements in high-growth environments through solution-driven approach.
Compliance Manager Product Development Quality
CSL
Parkville, Australia
08.2017 - 10.2019
- Led QA Compliance team to achieve compliance with GMP/PICS standards, ensuring product quality and safety.
- Coordinated preparation and execution processes, resulting in successful TGA audit outcomes.
- Executed internal audits across GMP, OECD, ISO 17025, and BioSafety/Biosecurity frameworks to assess and enhance regulatory adherence.
- Oversaw product complaints, recalls, investigations, and FMEAs.
- Site lead for global LIMS implementation, achieved go-live ahead of schedule.
- Directed LIMS data team in data extraction, analysis, migration.
- Developed strategy and project charter for global ERP system rollout, managing planning phases.
Senior Quality Systems Advisor (Product Development)
CSL
Parkville, Australia
09.2012 - 07.2017
- Achieved successful TGA audit and licensure for CMF fill and finish and freeze dry capacity expansion.
- Improved quality operations by applying value stream mapping to lean deviation management and QA batch release.
- Perform and approve Quality Risk Assessments to ensure a risk-based approach is applied to change and improvements.
- Chair Material Review Board (MRB) to approve raw materials and vendors for new clinical trial products.
- Manage R&D Quality projects, develop project strategy, planning, budgets, execution, and project closure.
- Author Quality Agreements for CSL Ltd CMOs/CROs and raw material suppliers.
- Review Pharmacopeia (USP/BP/EP) for excipients/chemical raw materials/pharmaceutical substances/medicinal products.
- Designed material lifecycle process for raw material management.
Buyer Planner
CSL
Parkville, Australia
08.2007 - 09.2012
- Manage multimillion dollar spend portfolio across CSL Biotherapies (BMW & PKV).
- Lead negotiations for total cost saving of $800,000 AUD across chemical portfolio.
- Negotiate contracts and agreements with external vendors (service/supply agreements).
- Managed critical material supply, including excipients, adjuvants, and APIs.
- Managed sourcing projects, overseeing project initiation, timelines, and resource planning.
- Data extraction, analysis and review to manage expired stock, stock approaching expiry, stock write-offs.
Production Specialist – Influenza Virus Vaccine
CSL Ltd
Parkville, Australia
11.2005 - 08.2008
- Coordinated downstream/solutions manufacturing area during FDA audit, ensuring audit preparedness for successful market application of Afluria vaccine in USA (BLA).
- Managed weekend operations of the Influenza Vaccine Manufacturing Plant with over 40 staff.
- Managed downstream solutions area in OGTR PC3 laboratory during pandemic campaign.
- Managed downstream/aseptic manufacturing operators, coaching and training staff to enhance operational effectiveness.
- Led audits for health authorities and internal (GMP, HS&E, QA, FDA and TGA), ensuring regulatory compliance and driving continuous improvement initiatives.
- Raise deviations, devise and implement CAPA, perform data analysis to support investigation results.
- Authored technical documents including SOPs and protocols to ensure departmental compliance.
Production Technician – Influenza Virus Vaccine
CSL Ltd
Parkville, Australia
10.2004 - 11.2005
- Performed Influenza vaccine inactivation and downstream sterile processing operations.
- Managed sterile raw materials and chemical supply via the ERP system.
- Validated inactivation assay (lowry) including operational qualification, and performance qualification.
English Teacher
Nova Intercultural Network
Tokyo, Japan
01.2002 - 01.2003
- Taught written and verbal English to non-English speaking students.
- Reviewed and wrote assessment reports to document student progress and guide instructional adjustments.
- Created comprehensive assessment reports to track and communicate student progress.
Education
Master of Biotechnology And Business (MBA) -
Royal Melb Institute of Tech University
Online 01.2015
Bachelor of Science -
Monash University
Melbourne, VIC01.2000
Bachelor of Arts -
Monash University
Melbourne, VIC01.1998
Diploma of Auditing -
SAI Global
Melbourne, VICSkills
- Quality management systems (including Veeva, TrackWise, Docnet)
- Regulatory compliance (GMP, GLP, GCP, ISO 17025)
- Regulatory audit management FDA, EMA, TGA, MHRA, Swiss Medic
- Laboratory management systems (STARLIMS, GLIMS, Labware)
- Analytical tools and extraction
- Data visualization techniques
- ERP systems (SAP, BPCS)
- Team leadership
- Coaching and mentoring
Memberships And Professional Training
- SOCRA – The Society of Clinical Research Associates
- RQA - Research Quality Association
- AusBiotech - Australia's peak biotechnology industry association
- Absanz – Association of Biosafety for Aus & NZ
Timeline
Associate Director Global R&D Quality
CSL
06.2023 - Current
Snr Manager Vendor Oversight Global R&D Quality
CSL
10.2019 - 06.2023
Compliance Manager Product Development Quality
CSL
08.2017 - 10.2019
Senior Quality Systems Advisor (Product Development)
CSL
09.2012 - 07.2017
Buyer Planner
CSL
08.2007 - 09.2012
Production Specialist – Influenza Virus Vaccine
CSL Ltd
11.2005 - 08.2008
Production Technician – Influenza Virus Vaccine
CSL Ltd
10.2004 - 11.2005
English Teacher
Nova Intercultural Network
01.2002 - 01.2003
Master of Biotechnology And Business (MBA) -
Royal Melb Institute of Tech University
Bachelor of Science -
Monash University
Bachelor of Arts -
Monash University
Diploma of Auditing -
SAI Global