Corporate IT Audit Senior Manager
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Jul 20, 2019
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Key responsibilities as part of this compliance team include:
- 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.
Basic Qualifications:
Doctorate degree and 2 years of corporate audit experience
OR
Master's degree and 4 years of corporate audit experience
OR
Bachelor's degree and 6 years corporate audit experience
OR
Associate's degree and 10 years corporate audit experience
Or
High school diploma / GED and 12 years corporate audit experience
Preferred Qualifications:
- 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 people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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