GCP Auditor - Global R&D Audit
Amgen
Summary
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.
Job description
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.
Key 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
Requirements
- 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
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Annual bonus program
- Stock-based long-term incentives
- Paid time-off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.