Quality Auditor Role at GSK
We are seeking a Quality Auditor to provide independent Quality Assurance within our R&D organization. In this role, you will deliver the audit program, including defining the scope of audits, conducting and reporting observations.
This 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.
You will also provide support QA activities during regulatory inspections, build solid working relationships with business stakeholders, and drive quality improvement of overall processes.
About This Role
This role is primarily aligned to Good Clinical Practices (GCP).
You will lead key activities to progress your career, which include:
* Planning, leading, and conducting routine and complex Quality Assurance audits of GSK studies, systems, processes, and external vendors to assess compliance with GCP and GSK policies/procedures, and applicable local regulations.
* Documenting objective and process-oriented audit findings in an audit report and obtaining robust CAPAs to address the findings and their root causes in a timely manner.
* Reporting and presenting findings from audits to relevant stakeholders and providing advice on compliance, quality improvement, and risk assessments.
* Supporting regulatory inspections for related authority inspections of GSK.
* Maintaining an up-to-date and in-depth knowledge of appropriate national and international GCP legislation and guidelines and relevant GSK processes and procedures.
Requirements
To be successful in this role, you should have:
* A 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 in the area related to Good Clinical Practice and/or experience as a Clinical Research Associate.
* Knowledge of global, regional, and national regulatory requirements and regulations.
* Excellent verbal, written communication, and presentation skills.
* Demonstrated analytical skills.
* Ability and desire for frequent domestic and international travel (approximately 25-40%).
PREFERRED QUALIFICATIONS
If you have the following characteristics, it would be a plus:
* Good knowledge of the drug development and clinical processes.
* Demonstrated experience interacting with regulatory agencies.
* Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization.
* Audit experience in Good Pharmacovigilance Practice and/or Good Laboratory Practice.