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Amgen Specialist - GxP Governance Deviation Management in Tampa, Florida

Job Title

Specialist - GxP Governance Deviation Management

Job Summary

This global technical role, reporting to the Principal - GxP Systems Governance & Assurance will be responsible for managing GxP Systems deviations for all IS systems and IS GxP processes and acting as the main link between the GxP Quality organization and IS management.

To be successful, you will require strong collaboration with IS Management, GxP Systems Quality and GxP Systems Audit, IS service and system owners, and other Amgen internal partners to maintain and enhance Amgen’s IS compliance landscape. Travel requirements may vary, depending on specific projects.

Key responsibilities

You will bring forth out of the box thinking, an agile mindset and substantial enterprise process ownership experience to empower application and product owners to build and maintain IT solutions with compliance, by design. You will become an advisor and an authority on GxP Systems deviation management for the IS organization.

You will perform the following activities and any additional tasks required to support and continuously improve Amgen's compliance posture, to effectively reduce risks and satisfy the security objectives of the organization.

  • Serve as the GxP deviation SME for IS users and be accountable for ensuring GxP compliance within IS by timely and effectively managing deviations.

  • Ensure operational alignment with GxP Systems Quality team on quality requirements and support IS management in all phases of the quality deviation management process.

  • Be part of the global GxP deviation network, representing the IS organization.

  • Manage GxP systems deviations and deliver trend deviations for IS.

  • Contribute to the strategic development of the GxP Systems compliance by supporting the development and maintenance of a governance framework to measure, monitor and manage GxP systems compliance.

  • Measure and monitor GxP systems compliance, from a GxP deviations perspective.

  • Assist in the review of GxP deviation process updates and documentation (e.g. SOPs, PLANs, TPLs) as changes are periodically introduced, providing IS input

Minimum Qualifications

  • Master’s degree and 8 years of Information Systems experience

  • OR

  • Bachelor’s degree and 10 years of Information Systems experience

Preferred Qualifications

  • Bachelor’s degree in computer information systems, computer science, or equivalent experience

  • 5+ years of experience in Information Technology, IT Compliance, IT Service Management, IT project management, IT audits

  • 3+ years of experience within biotechnology / pharmaceutical industry

  • Expert knowledge of GxP computerized systems compliance requirements and deviation management

  • Familiar with Quality Assurance Systems in relation to deviations management and CAPAs

  • Ability to facilitate execution of the deviation process and project manage the investigation

  • Proven working knowledge of information systems concepts, compliance principles and security pillars (confidentiality, integrity and availability)

  • Strong problem-solving skills and understanding of causal factor analysis

  • Expert knowledge of different root cause analysis (RCA) methodologies

  • Technical writing skills to facilitate triage, initiation, scoping, managing, and updating deviation records

  • Effective communication with leadership and medium audience discussions / presentations / interviews

  • Experience working with various technologies, IT frameworks and methodologies

  • Must have strong organizational and communication skills

  • Working in large corporate environments involving multiple businesses and diverse stakeholders.

  • Demonstrated ability to understand and adapt to new technologies and other paradigms such as cloud, emerging Big Data technologies, lean methodologies.

  • Exceptional teaming skills encompassing cross-functional teams, peer relationships, informing, understanding and appreciating differences

  • Strong ability to convey and influence complex compliance, information risk and security issues in a manner that is easily understood and actionable

  • Demonstrated ability to effectively facilitate and drive organizational change

  • Developing / delivering presentations to large audiences and at all levels within the organization

  • Accepts responsibility and personal accountability.

Join Us

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.

Amgen requires all staff in the United States and Puerto Rico 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.

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