GCP Auditor - Global R&D Audit

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.

Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.

If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do Let’s do this. Let’s change the world. You would be joining Amgen’s R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group. In this vital role within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities.

You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:

• 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.

• Doctorate degree OR Master’s degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR Bachelor’s degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR Associate’s 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

• Postgraduate qualification Participation in process improvement initiatives.
• Extensive experience conducting international auditing in GCP or as a regulatory authority inspector
• Experience of data mining, manipulation and data analytics would be advantageous
• Excellent written and verbal communication skills

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an Final date to…