Global GCP Auditor & R&D Quality Lead

Amgen; United States; Remote; USD 105,000 - 142,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a GCP Auditor for the Global R&D Audit team. You will plan, conduct and report audits across a global remit, lead complex GCP audits and support regulatory inspections as needed. This role requires staying ahead of compliance risks and contributing to quality process improvements.

You may travel up to 40% internationally and will engage with cross-functional teams to ensure rigorous clinical trial governance throughout development and post-marketing activities.

Qualifications

• Doctorate degree or Master’s with 2 years of scientific discipline, medical sciences or pharmacy experience or Bachelor’s with 4 years, or Associate’s with 8 years, or high school diploma with 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 development of R&D Quality cross functional controlled documents.

Skills

Excellent written and verbal comms

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Associate’s degree + 8 years experience

High school diploma / GED + 10 years experience

Job description

Amgen is seeking a GCP Auditor for the Global R&D Audit team. You will plan, conduct and report audits across a global remit, lead complex GCP audits and support regulatory inspections as needed. This role requires staying ahead of compliance risks and contributing to quality process improvements.

You may travel up to 40% internationally and will engage with cross-functional teams to ensure rigorous clinical trial governance throughout development and post-marketing activities.