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2 days ago
The primary goal of this role is to oversee the day-to-day operations within a vendor qualification team. This involves strategic planning and coordination with external auditors.
- Build strong working relationships with various teams to support vendor management;
- Contribute to the development of audit schedules, quality metrics, and reports;
- Drive process improvements by reviewing and updating procedural documentation;
- Support the strategic planning of vendor assurance initiatives;
In addition to vendor qualification, you will also contribute to broader QA activities including:
- Delivering compliance advice to stakeholders;
- Conducting internal and external audits to ensure adherence to regulatory requirements;
- Supporting sponsor audits and inspections to maintain quality standards;
- Reviewing and improving QA processes to enhance overall performance;
To be successful in this role, we are looking for candidates with the following qualifications:
- A minimum of 5 years' experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials; preferred experience includes CROs;
- Strong knowledge of quality assurance activities and understanding of vendor oversight strategies in regulated environments is essential;
- Strong background in QA and GxP auditing, especially GCP, is required, and experience across other GxP areas (GLP, GPvP, GMP, GDP) is beneficial;
- Critical thinking skills with a proactive, solutions-focused mindset are necessary;
- Ability to travel across regions if required; and
- Relevant tertiary qualifications in medical, pharmaceutical, or healthcare disciplines (MSc or PhD is highly desirable).
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