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 and procedures, and accepted principles and guidelines. Additionally, you will support QA activities during regulatory inspections, build strong relationships with business stakeholders, and drive overall process quality improvements.
This role primarily focuses on Good Clinical Practices (GCP).
Key responsibilities include:
1. Planning, leading, and conducting routine and complex QA audits of GSK studies, systems, processes, and external vendors to assess compliance with GCP, GSK policies, and applicable regulations.
2. Documenting audit findings objectively and process-orientedly in reports, and ensuring timely implementation of robust CAPAs to address findings and root causes.
3. Reporting and presenting audit findings to stakeholders and advising on compliance, quality improvements, and risk assessments.
4. Supporting regulatory inspections related to GSK.
5. Maintaining up-to-date knowledge of GCP legislation, guidelines, and GSK processes.
6. Building and maintaining beneficial relationships with quality and compliance groups and internal/external customers.
7. Working independently and collaboratively within teams.
Basic Qualifications:
* Bachelor’s degree in a related Health Science field or equivalent.
* Experience in the pharmaceutical industry and/or quality assurance.
* Previous experience with 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.
Application deadline: 24/04/2025
Why GSK?
GSK is a global biopharma company committed to uniting science, technology, and talent to advance health and address diseases worldwide. We focus on vaccines, medicines, and the science of the immune system, investing in key therapeutic areas such as infectious diseases, HIV, respiratory/immunology, and oncology.
Our success depends on our people. We aim to create an inclusive environment where everyone can thrive, be themselves, and grow while contributing to our mission to get ahead of disease together.
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