Global GCP Auditor, R&D Quality & Compliance Lead

BioSpace; Washington (District of Columbia); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Annual bonus program

Stock-based incentives

Generous time-off plans

Flexible work models

Job summary

Amgen is hiring a GCP Auditor to join the Global R&D Audit team. You will conduct and lead international GCP audits across Amgen’s portfolio, supporting regulatory inspections and driving risk-based quality improvements in a cross-functional setting.

Ideal candidates have advanced degrees and substantial experience in science, medicine, or pharmacy, and are willing to travel up to 40% to international destinations. Amgen values collaboration and patient-focused results.

Qualifications

• Doctorate degree or
• Masters degree and 2 years of scientific discipline, medical sciences or pharmacy experience or
• Bachelors degree and 4 years of scientific discipline, medical sciences or pharmacy experience or
• Associates degree and 8 years of scientific discipline, medical sciences or pharmacy experience or
• High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy 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/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
• The role can entail up to 40% travel to international destinations

Skills

GCP auditing

Regulatory inspections

International audits

Quality assurance

Communication skills

Education

Doctorate degree

Masters degree + 2 years relevant experience

Bachelors degree + 4 years relevant experience

Associates degree + 8 years relevant experience

High school diploma + 10 years relevant experience

Job description

Amgen is hiring a GCP Auditor to join the Global R&D Audit team. You will conduct and lead international GCP audits across Amgen’s portfolio, supporting regulatory inspections and driving risk-based quality improvements in a cross-functional setting.

Ideal candidates have advanced degrees and substantial experience in science, medicine, or pharmacy, and are willing to travel up to 40% to international destinations. Amgen values collaboration and patient-focused results.