
Lead Quality Assurance Specialist
23 hours ago
The main focus of this position is to lead and manage daily vendor qualification operations within the quality assurance team.
- Coordinate with external auditors to oversee vendor selection, assessments, and qualifications;
- Act as a subject matter expert in internal forums and vendor-related meetings to share knowledge and expertise;
- Develop strong relationships with internal teams and external partners to support vendor use and management;
This role contributes to broader quality assurance activities including:
- Providing compliance advice;
- Conducting internal and external audits;
- Supporting sponsor audits and inspections;
- Reviewing and improving QA processes;
We are looking for candidates who possess:
- A minimum of 5 years' experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials, preferably with CRO experience;
- Strong knowledge of Vendor Management Quality Assurance activities and understanding of vendor oversight strategies in regulated environments;
- A strong background in QA and GxP auditing, especially GCP is essential and experience across other GxP areas (GLP, GPvP, GMP, GDP) is beneficial;
- Critical thinking skills with a proactive, solutions-focused mindset;
- The ability to travel across regions if required;
- Relevant tertiary qualifications in medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).
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