Senior Quality Assurance Specialist
2 days ago
As a senior quality assurance professional, you will lead and manage daily vendor qualification operations within our team. Your expertise will be pivotal in overseeing vendor selection, assessments, and qualifications, including coordination with external auditors.
- Act as subject matter expert in internal forums and vendor-related meetings;
- Establish strong relationships with internal teams and external partners to support vendor use and management;
- Contribute to the development of audit schedules, quality metrics, and reports;
- Drive process improvement by reviewing and updating procedural documentation;
- Support the strategic planning of vendor assurance initiatives; and
- Perform additional responsibilities as assigned.
Beyond vendor qualification, you will also contribute to broader quality assurance activities, including delivering compliance advice, conducting internal and external audits, supporting sponsor audits and inspections, reviewing and improving QA processes; and performing additional responsibilities as assigned.
Key RequirementsTo be successful in this role, we are looking for candidates with a minimum of 5 years' experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials. Strong knowledge of CRO / Healthcare / Pharmaceutical Vendor Management Quality Assurance activities and understanding of vendor oversight strategies in regulated environments is essential.
- Strong background in QA and GxP auditing, especially GCP, is essential. Experience across other GxP areas (GLP, GPvP, GMP, GDP) is advantageous;
- Critical thinker with a proactive solutions-focused mindset;
- Ability to travel across the region if required; and
- Appropriate tertiary qualifications in medical pharmaceutical or healthcare disciplines, MSc or PhD is highly desirable.
We offer a unique opportunity to contribute to our expansion into the APAC region and join a passionate team committed to quality collaboration and continuous improvement. We prioritize work-life balance, flexibility, and career stability and security.
What We Offer- An attractive remuneration package;
- Genuine work-life balance;
- Flexibility and discussion options to meet your work/life commitments and support your wellbeing;
- Career stability and security; and more.
We value diversity and inclusion and strive to create a safe and inclusive environment that celebrates the diversity of our employees.
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