GCP Auditor – Global R&D Audit

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, execute, and report on routine and direct GCP compliance audits on a global scale.

• Act as the lead auditor for intricate GCP audits.

• Recognize and communicate compliance risks to the R&D Quality management team.

• Facilitate and/or participate in inspections by regulatory authorities.

• Contribute to or spearhead initiatives aimed at improving R&D Quality processes.

• Author and assist in the creation of controlled documents that are cross-functional within R&D Quality.

• Provide support during regulatory inspections of clinical sites and Amgen facilities.

⛳️ Requirements

• Doctorate degree OR

• Master’s degree with 2 years of experience in scientific discipline, medical sciences, or pharmacy OR

• Bachelor’s degree with 4 years of experience in scientific discipline, medical sciences, or pharmacy OR

• Associate’s degree with 8 years of experience in scientific discipline, medical sciences, or pharmacy OR

• High school diploma / GED with 10 years of experience in scientific discipline, medical sciences, or pharmacy.

• Postgraduate qualification.

• Experience participating in process improvement initiatives.

• Extensive background in conducting international GCP audits or serving as a regulatory authority inspector.

• Experience in data mining, manipulation, and analytics is a plus.

• Exceptional written and verbal communication skills.

• Willingness to travel internationally, up to 40%.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous contributions from the company.

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work arrangements where feasible.

• Opportunities for career development.

• Financial plans that allow saving towards retirement or other objectives.

• Support for work/life balance.