Global GCP Auditor - R&D Quality & Compliance Lead
Amgen SA
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Benefits offered by this job
Job summary
Amgen seeks a GCP Auditor to join the R&D Quality Audit Team, conducting global audits of clinical trials and supporting regulatory inspections across Amgen's portfolio.
You will plan, perform, and report audits, lead complex reviews, and identify compliance risks. Travel up to 40% internationally, with opportunities to impact development and post-marketing activities.
Join a collaborative, science-based culture focused on serving patients and advancing Amgen's quality programs.
Qualifications
- Doctorate degree or equivalent in a scientific discipline, medical sciences, or pharmacy.
- Master's degree with 2 years of scientific discipline, medical sciences or pharmacy experience OR
- Bachelor's degree with 4 years of experience in scientific discipline, medical sciences or pharmacy OR
- High school diploma with 10 years of related scientific experience.
Responsibilities
- Plan, conduct and report routine and direct GCP compliance audits internationally.
- Serve as a lead auditor for complex GCP audits.
- Identify and communicate compliance risks to R&D Quality management.
- Host and participate in regulatory authority inspections as needed.
- Contribute to or lead R&D Quality process improvement initiatives.
Skills
Education
Job description
Amgen seeks a GCP Auditor to join the R&D Quality Audit Team, conducting global audits of clinical trials and supporting regulatory inspections across Amgen's portfolio.
You will plan, perform, and report audits, lead complex reviews, and identify compliance risks. Travel up to 40% internationally, with opportunities to impact development and post-marketing activities.
Join a collaborative, science-based culture focused on serving patients and advancing Amgen's quality programs.
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