Senior Quality Assurance Auditor

Senior Quality Assurance Auditor

As a Quality Auditor you will provide independent Quality Assurance within GSK R&D by delivering the audit program, including defining 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 provide 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 to Good Clinical Practices (GCP).

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Independently plan, lead, and conduct routine and complex Quality Assurance audits of GSK studies, systems, GSK processes and external vendors to assess compliance with GCP and GSK policies and procedures, and applicable local regulations.
• Document objective and process-oriented audit findings in an audit report and obtain robust CAPAs to address the findings and their root causes in a timely manner.
• Report and present findings from audits to relevant stakeholders and provide advice on compliance, quality improvement and risk assessments.
• Support regulatory inspections for related authority inspections of GSK.
• Maintain an up to date and in-depth knowledge of appropriate national and international GCP legislation and guidelines and  relevant GSK processes and procedures.
• Build and maintain beneficial working relationship with other quality and compliance groups and relevant internal/external customers.
• Work independently and as a member of assigned team.

Why you?

Basic Qualifications

We are looking for professionals with following required skills to achieve our goals:

• Bachelor’s degree in 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 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%)
• Fluent English

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

Job posting end date: 24/04/2025

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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