As a Quality Auditor, you will provide independent Quality Assurance within GSK R&D by delivering the audit program, including defining the scope of audits, conducting, and reporting observations. This role involves identifying compliance issues and trends within R&D to ensure adherence to relevant international regulatory agency regulations, GSK policies/procedures, and accepted principles/guidelines. Additionally, you will support QA activities during regulatory inspections, build strong relationships with business stakeholders, and drive quality improvements across processes.
Primary Focus
This role is primarily aligned with Good Clinical Practices (GCP).
Key Responsibilities
1. Plan, lead, and conduct routine and complex QA audits of GSK studies, systems, processes, and external vendors to assess compliance with GCP, GSK policies, and local regulations.
2. Document audit findings clearly in reports and develop robust CAPAs to address root causes promptly.
3. Present audit findings to stakeholders and advise on compliance, quality improvement, and risk management.
4. Support regulatory inspections related to GSK.
5. Maintain current knowledge of GCP legislation, guidelines, and GSK processes.
6. Build and nurture collaborative relationships with quality teams and external partners.
7. Work independently and collaboratively within teams.
Qualifications
Basic Qualifications:
* Bachelor's degree in a related health science field or equivalent.
* Experience in the pharmaceutical industry and/or quality assurance.
* Experience with GCP and auditing or as a Clinical Research Associate.
* Knowledge of global and regional regulatory requirements.
* Strong communication, analytical, and presentation skills.
* Willingness to travel domestically and internationally (approx. 25-40%).
Preferred Qualifications:
* Knowledge of drug development and clinical processes.
* Experience with regulatory agency interactions.
* Ability to manage global projects in diverse cultural settings.
* Experience with pharmacovigilance or laboratory practices is a plus.
Additional Information
Application deadline: 24/04/2025
Why Join GSK?
GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease. We focus on vaccines, medicines, and innovative data technologies across core therapeutic areas. Our success depends on our people, and we strive to create an inclusive environment where everyone can thrive, grow, and contribute to our mission of improving health worldwide.
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