Global GCP Auditor – R&D Quality & Compliance Lead

Amgen Inc.; United States; On-site; USD 105,000 - 142,000; Full time

Job summary

Amgen is seeking a GCP Auditor for Global R&D Audit. You will plan, conduct and report GCP compliance audits across a global remit, including potential regulatory inspections of clinical sites and Amgen facilities.

You may work on cross-functional controlled documents and drive process improvements within R&D Quality. The role emphasizes travel up to 40% internationally and requires advanced degrees in scientific disciplines with substantial audit experience.

Qualifications

• Doctorate, or Master’s with 2+ years in scientific discipline, medical sciences or pharmacy.
• Bachelor’s with 4+ years, or Associate with 8 years, or High school diploma with 10 years in relevant field.
• Preferred: postgraduate qualification.

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/or play a role in regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.
• Author and contribute to the development of R&D Quality cross functional controlled documents.

Skills

GCP auditing

Regulatory inspections

Data analytics

Communication skills

Education

Doctorate degree

Master’s degree in scientific discipline/medical sciences/pharmacy

Bachelor’s degree with 4+ years experience

Associate’s degree with 8+ years experience

High school diploma / GED with 10 years experience

Job description

Amgen is seeking a GCP Auditor for Global R&D Audit. You will plan, conduct and report GCP compliance audits across a global remit, including potential regulatory inspections of clinical sites and Amgen facilities.

You may work on cross-functional controlled documents and drive process improvements within R&D Quality. The role emphasizes travel up to 40% internationally and requires advanced degrees in scientific disciplines with substantial audit experience.