Global GCP Audit Lead – R&D Compliance

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Group medical, dental and vision

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen seeks a GCP Auditor for the Global R&D Audit team to plan, conduct and report global GCP audits across Amgen’s portfolio. You will lead complex audits, identify compliance risks, and support regulatory inspections, contributing to process improvements within R&D Quality.

The role requires extensive international auditing experience, strong communication skills, and the ability to travel up to 40% to international destinations.

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

Skills

GCP audit experience

International audits

Regulatory inspections

Data analytics

Communication skills

Education

Doctorate degree

Master's degree + 2 years experience

Bachelor's degree + 4 years experience

Associates degree + 8 years experience

High school diploma + 10 years experience

Job description

Amgen seeks a GCP Auditor for the Global R&D Audit team to plan, conduct and report global GCP audits across Amgen’s portfolio. You will lead complex audits, identify compliance risks, and support regulatory inspections, contributing to process improvements within R&D Quality.

The role requires extensive international auditing experience, strong communication skills, and the ability to travel up to 40% to international destinations.