At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
GCP Quality Auditor (m/f/d)
As a GCP Quality Auditor, you will provide independent Quality Assurance within GSK R&D by delivering the audit program, including defining the scope of audits, conducting them, and reporting observations. The role involves identifying compliance issues and trends within R&D to ensure adherence to international regulatory requirements, GSK policies and procedures, and accepted principles/guidelines. Additionally, you will support QA activities during regulatory inspections, build strong working relationships with business stakeholders, and drive continuous quality improvement across processes.
This role is primarily aligned to Good Clinical Practices (GCP).
Main Responsibilities:
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 local regulations.
2. Document objective and process-oriented audit findings in an audit report and ensure robust CAPAs to address findings and their root causes in a timely manner.
3. Report and present findings from audits to relevant stakeholders and provide advice on compliance, quality improvement, and risk assessments.
4. Support regulatory inspections related to GSK.
5. Maintain up-to-date and in-depth knowledge of national and international GCP legislation, guidelines, and relevant GSK processes and procedures.
6. Build and maintain beneficial working relationships with other quality and compliance groups and relevant internal/external customers.
7. Work independently and as part of an assigned team.
Qualifications & Skills:
8. Bachelor’s degree in a related Health Science field or equivalent.
9. Experience in the pharmaceutical industry and/or quality assurance, including auditing in GCP and/or experience as a Clinical Research Associate.
10. Strong knowledge of Good Clinical Practice (GCP) and global, regional, and national regulatory requirements.
11. Fluent in English, with excellent verbal, written, and presentation skills.
12. Demonstrated analytical skills.
13. Ability and willingness to travel frequently, both domestically and internationally (approximately 25-40%).
Preferred Qualifications & Skills:
14. Good knowledge of drug development and clinical processes, with experience interacting with regulatory agencies.
15. Proven ability to manage global projects and programs in a culturally diverse organization.
16. Audit experience in Good Pharmacovigilance Practice and/or Good Laboratory Practice.
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Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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