Job Title: Quality Auditor (GCP)
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, trends within the scope of R&D to ensure compliance with relevant international regulatory agency regulations, GSK policies/procedures, and accepted principles/guidelines. Additionally, you will support QA activities during regulatory inspections, build solid working relationships with business stakeholders, and drive quality improvement of overall processes. This role is primarily aligned with Good Clinical Practices (GCP).
This position offers you the opportunity to lead key activities to advance your career. Responsibilities include:
1. Independently plan, lead, and conduct routine and complex Quality Assurance audits of GSK studies, systems, processes, and external vendors to assess compliance with GCP, GSK policies, and applicable regulations.
2. Document audit findings objectively and process-orientedly in reports, and ensure robust CAPAs to address findings and root causes promptly.
3. Report and present audit findings to relevant stakeholders, providing advice on compliance, quality improvement, and risk assessment.
4. Support regulatory inspections related to GSK.
5. Maintain up-to-date knowledge of national and international GCP legislation, guidelines, and relevant GSK processes and procedures.
6. Build and sustain beneficial working relationships with quality and compliance groups, and internal/external customers.
7. Work independently and collaboratively within assigned teams.
Qualifications
Basic Qualifications:
* Bachelor's degree in a related Health Science field or equivalent.
* Experience in the pharmaceutical industry and/or quality assurance.
* Previous experience in Good Clinical Practice (GCP).
* Auditing experience related to GCP or experience as a Clinical Research Associate.
* Knowledge of global, regional, and national regulatory requirements.
* Excellent communication and presentation skills.
* Strong analytical skills.
* Willingness and ability to travel domestically and internationally (approximately 25-40%).
Preferred Qualifications:
* Knowledge of drug development and clinical processes.
* Experience interacting with regulatory agencies.
* Ability to manage global projects in a culturally diverse environment.
* Audit experience in Pharmacovigilance or Laboratory practices.
Additional Information
Job posting end date: 24/04/2025
Why GSK?
GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease. We focus on vaccines, medicines, and the science of the immune system across core therapeutic areas. Our success depends on our people, and we strive to create an inclusive environment where everyone can thrive. Join us in our journey to make a difference and get ahead together.
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