Corporate Audit - R&D IT Audit Manager - (US remote)
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Corporate Audit - R&D IT Audit Manager - (US remote)Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will ensure that Amgen good practice activities are conducted in accordance with regulations, policies and procedures. While reporting to our Director of Corporate IT Audit, the Manager will work with the Research and Development and Corporate Quality audit teams across global locations.Responsibilities:
- Participating in Internal Process & Service Providers audits to ensure compliance with good practices guidelines, FDA Part 11 regulations and Amgen Standard Operating Procedures
- Lead or participate in Systems Audits including the development of audit plans, tools, and conduct
- Detail and summarize auditing results and findings, including recommendations for corrective action or controls for risk mitigation
- Obtain audit responses from company functions or vendors and evaluate proposed Corrective Action Preventive Action (CAPA) for adequacy if implemented successfully
- Provide interpretation for internal and external customers on Code of Federal Regulations: Title 21, Part 11, International Conference on Harmonization guidelines for electronic company systems
- Give quality compliance data for metrical analysis
- Identify matters that require elevation to senior management on mitigation of risk and improving the efficiency of the Compliance Program
- Travel could include up to 30% domestic and international.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek possesses these qualifications.
Master’s degree and 2 years of IT audit experienceOr
Bachelor’s degree and 4 years of IT audit experienceOr
Associate’s degree and 10 years of IT audit experienceOr
High school diploma / GED and 12 years of IT audit experience
- 6+ years of audit or compliance related experience in the biotechnology or pharmaceutical industry, with + years of experience in an IT compliance/validation/quality role
- Experience in performing or supporting IT system audits or validation activities
- Proficiency in GxP Guidelines and regulatory requirements for the conduct of clinical trials and manufacturing of pharmaceutical products
- External audit (Third Party GLP/GCP/GMP vendors) and internal audit experience
- Knowledge and understanding of the internal control framework
- Experience with data analytics and data mining skills, including use of current analytical/BI tools for data analysis (Tableau, Spotfire, AMS)
- Ability to balance multiple activities in a fast-paced environment while delivering a timely and high-quality end work product
- Self-starter with excellent audit management and communication (both verbal and written) skills, including the ability to effectively and confidentially interact with Amgen senior management
- Strong social skills, with ability to forge collaborative relationships with all levels and functions of the organization
- Ability to prepare and present analytical written and oral communications appropriate for multiple audiences Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.