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Amgen Principal, Information Systems – GxP Systems Governance & Assurance in Tampa, Florida

Job Title

Principal, Information Systems – GxP Systems Governance & Assurance

Job Summary

This global technical role, reporting to the Senior Manager – IS & Info Sec Governance & Assurance will be responsible for managing and improving governance and compliance processes for GxP systems managed by the IS organization, by taking ownership of GxP systems governance and assurance, GxP systems deviation management oversight, IS Document Management for GxP requirements, GxP Audits and GxP Inspection Readiness and Response.

To be successful, you will require strong collaboration with the Information Systems (IS) Leadership Team, 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 governance throughout 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.

  • Provide a methodical approach to managing GxP compliance within IS, including deviations, by designing and implementing the accountability framework which provides visibility and oversight to ensure that GxP compliance risks and audit/inspection actions are adequately addressed.

  • Oversee GxP systems deviation management for all IS systems and IS GxP processes

  • Establish metrics control plan between Quality and IS for periodic measurements

  • Oversee GxP audit and inspection preparation and response.

  • Represent IS function in the global GxP deviation network

  • Work closely with GxP Systems Quality and GxP Systems Audit teams to promote compliance with GxP requirements.

  • Contribute to the strategic development of the IS Governance Framework by supporting the development and maintenance of IS and information security policies, standards, and guidelines in alignment with GxP requirements, applicable laws, and common industry frameworks.

  • Oversee the management of GxP IS regulated documents.

  • Develop, maintain and improve process documents for owned service.

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

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

  • 5+ years of experience within biotechnology / pharmaceutical industry

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

  • Expert knowledge of GxP computerized systems compliance requirements, US and global

  • Familiar with various Quality Assurance Systems in relation to SOP management, training, deviations/CAPAs, change management/control, risk management and continuous improvement

  • Experience in a GxP regulated, quality function in a biopharmaceutical company or Clinical Research Organization (CRO)

  • Effective communication with senior leadership and medium to large audience discussions / presentations

  • 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.

  • Experience authoring IT policies and methodologies to include compliance and security requirements

  • Experience working in Agile and/or DevOps teams (SCRUM)

  • Working experience with Governance, Risk and Compliance (GRC) Tools

  • Demonstrated ability to understand the concepts of new cloud technologies and other paradigms such as emerging Big Data technologies, lean methodologies to propose appropriate controls and compliance guidance.

  • 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

  • Demonstrated leadership skills.

  • Accepts responsibility and personal accountability.

  • One or more industry recognized certifications, including but not limited to:

  • Certified Information Security Manager (CISM)

  • Certified Information Systems Security Professional (CISSP)

  • SANS Global Information Assurance Certifications (GIAC)

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.