Hybrid GCP Quality Auditor – m/f/d

Posted last month

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About the role

  • 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
  • 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
  • Report and present findings from audits to relevant stakeholders and provide advice on compliance, quality improvement, and risk assessments
  • Support regulatory inspections related to GSK
  • Maintain up-to-date and in-depth knowledge of national and international GCP legislation, guidelines, and relevant GSK processes and procedures
  • Build and maintain beneficial working relationships with other quality and compliance groups and relevant internal/external customers

Requirements

  • Bachelor’s degree in a related Health Science field or equivalent
  • Experience in the pharmaceutical industry and/or quality assurance, including auditing in GCP and/or experience as a Clinical Research Associate
  • Strong knowledge of Good Clinical Practice (GCP) and global, regional, and national regulatory requirements
  • Fluent in English, with excellent verbal, written, and presentation skills
  • Demonstrated analytical skills
  • Ability and willingness to travel frequently, both domestically and internationally (approximately 25-40%)

Benefits

  • Health insurance
  • Professional development opportunities
  • Paid time off

Job title

GCP Quality Auditor – m/f/d

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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