Vacancies for Administrative and Technical Staff
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Department: Family Medicine and Population Health
Regime Full-time
Let's shape the future - University of Antwerp
The University of Antwerp is a dynamic, forward-thinking university. We offer an innovative academic education to more than 20,000 students, conduct pioneering scientific research and play an important service-providing role in society. With more than 6000 employees from 100 different countries, we are helping to build tomorrow’s world every day. Together we push back boundaries and set a course for the future – a future that you can help to shape.
The Global Health Institute (GHI) of the Faculty of Medicine and Health Sciences at University of Antwerp (UAntwerp) is looking for a
Full-time (100%) Quality Assurance Specialist
The GHI’s mission is to conduct research aimed at improving the health of people worldwide, build capacity for global health research and engage in the implementation and evaluation of evidence-based interventions for health problems in low- and middle-income countries. Research activities cover different areas such as reproductive health, chronic disease management, (neglected) infectious diseases and vaccine-preventable diseases (www.uantwerpen.be/en/rg/global-health-institute).
Background
Vaccine research in low- and middle-income countries is essential for strengthening preparedness and response to infectious diseases such as mpox, Ebola, and other epidemic-prone pathogens. As a sponsor of several vaccine trials in the Democratic Republic of the Congo (DRC), the Global Health Institute is looking for an experienced Quality Assurance (QA) Specialist to support the monitoring and quality oversight within vaccine trials.
The Sponsor QA position ensures that all clinical trial activities conducted under the Sponsor’s responsibility comply with ICH GCP, applicable regulatory requirements, and funder policies, and the Sponsor’s Quality Management System. The role provides independent oversight, conducts GxP audits, and verifies that delegated activities (Contract Research Organizations (CROs), vendors, laboratories, investigator sites) are performed in accordance with contractual obligations and regulatory expectations.
Position
- Maintain and continuously improve the Sponsor’s Quality Management System (QMS).
- Ensure SOPs are current, aligned with ICH GCP E6 (R2/R3), GxP guidance, and funder requirements.
- Contribute to development and review of quality plans for funded trials.
- Plan, execute, and report risk‑based QA audits of:
- CROs
- Investigator sites
- Laboratories (central & local)
- Vendors (labs, logistics, pharmacovigilance)
- Clinical systems (Electronic data capture, Pharmacovigilance (PV) systems,…)
- Trial Master File (TMF)
- Perform follow-up verification of Corrective and Preventive Actions (CAPAs).
- Provide independent verification of sponsor oversight, including documentation of decisions, escalations, risk management, and vendor performance.
- Participate in governance meetings as QA representative (without operational responsibilities).
- Review risk assessments, risk control measures, and Risk-Based Quality Management implementation.
- Assess whether risk signals are detected, escalated, and mitigated appropriately.
- Evaluate clinical systems for compliance with data integrity standards (ALCOA+).
- Verify user access governance, audit trails, system validation, and data flow controls.
- Audit safety reporting processes, SAE/SUSAR workflows, and PV vendor activities.
- Ensure data reconciliation processes are compliant and documented.
- Lead preparation for regulatory inspections, Funder GxP Quality Assessments and audits.
- Conduct mock inspections, TMF checks, and readiness assessments.
- Develop and deliver training on GCP, GxP, quality systems, and audit readiness.
- Identify systemic issues, drive continuous improvement, and promote a quality‑centric culture.
Profile
- Master’s degree in Life Sciences, Pharmacy, Medicine, Public Health, Quality Management, or related field.
- Minimum 2-5 years of experience in clinical research, ideally including QA or auditing roles.
- Excellent knowledge of English and good knowledge of French. Dutch is not required but is an asset.
- Strong understanding of clinical development processes and regulatory frameworks.
- Training in audit methodology (internal/external auditor training preferred).
- Ability to apply risk-based principles to QA and oversight.
- Strong root cause analysis and CAPA management skills.
- Excellent communication, diplomacy, and cross-functional engagement skills.
- Ability to work independently, maintain objectivity, and ensure confidentiality.
- Demonstrated experience with:
- ICH GCP
- QMS
- QA audits
- Clinical operations
- Vendor/CRO management
- TMF requirements
- Pharmacovigilance processes
- Laboratory standards (GCLP preferred)
- Preferred Certifications, not required but advantageous:
- RQA (formerly BARQA) certification
- ASQ Certified Quality Auditor (CQA)
- DIA GCP/QA Auditor training
- ISO 9001, ISO 14155 or relevant QMS training
- Willing to travel to partners and trial settings located in the Global South, if required.
- Experience working in remote settings in Africa is a great asset.
Reporting
You will report to and be supervised by a lead project manager at the University of Antwerp, who has a direct functional link with the Principal Investigators of the clinical trial.
What we offer
- Working in an intellectually stimulating, international and interdisciplinary research environment, with room for personal initiative;
- A fixed-term contract of 12 months for 1 FTE position with a possibility of extension pending funding;
- Start date: ASAP or September 2026 at the latest;
- You will receive a gross monthly salary within pay band 7.1 – 9.1 of the pay scales of the Administrative and Technical Staff. Your entry-level grade depends on your relevant professional experience. More information on our pay scales and other benefits can be found here on our website.
- You get meal vouchers, eco vouchers, internet connectivity allowance, group insurance, guaranteed income insurance, and a bicycle allowance or full reimbursement of your commute by public transport;
- You will work largely at Campus Drie Eiken with in a dynamic and stimulating working environment and flexible working time arrangements (possibility to work from home 2-3 days a week).
- Find out more about working at the University of Antwerp and discover all the additional benefits we offer.
Want to apply
- You can apply for this job through the University of Antwerp’s online job application platform until August 3, 2026, 24h CET. Click on ‘apply for job’, complete the online application form and don’t forget to include the following document: motivation letter and your CV.
- The selection committee will review all applications as soon as possible after the application deadline. Once a decision has been made, we will notify you and inform you of the possible next step(s) in the selection procedure.
- If you have any questions about the content of the job or the relevant projects, please contact the project managers, Dr. Maha Salloum, maha.salloum@uantwerpen.be, or Dr. Ynke Larivière, ynke.lariviere@uantwerpen.be, or the head of GHI, Prof. Jean-Pierre Van geertruyden, jean-pierre.vangeertruyden@uantwerpen.be. If you have any questions about the online application form, please check the Frequently Asked Questions or send an email to jobs@uantwerp.be.
The University of Antwerp is a sustainable, family-friendly organisation which invests in its employees’ growth. We aim to foster diversity and attach great importance to equal opportunities, regardless of gender identity (M/F/X), disability, race, ethnicity, religion or belief, sexual orientation or age. We encourage people from diverse backgrounds and with diverse characteristics to apply.