Corporate IT Audit Senior Manager
- 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
- Contribute 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.
Doctorate degree and 2 years of corporate audit experience
Masters degree and 4 years of corporate audit experience
Bachelors degree and 6 years corporate audit experience
Associates degree and 10 years corporate audit experienceOr
High school diploma / GED and 12 years corporate audit experience
- 10+ years of audit or compliance related experience in the biotechnology or pharmaceutical industry, with 5+ 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 interpersonal 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.
Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment.
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.
Join UsIf 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.