Information Security GxP Specialist

Role Description: Let’s do this. Let’s change the world. In this vital role you will involve working closely with various groups to ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, and supporting regulatory compliance efforts.

GxP Deviation and CAPA Management:

• Manage and own technology related GxP deviations, CAPA, and CAPA-EV records
• Manage GxP reporting and monitoring metrics for Technology/IT records
• Collaborate with record owners and QA to ensure timely record resolution
• Assist in the identification and evaluation of risks associated with GxP deviation records.
• Identify and support new record owners across IT/Technology (e.g. office hours, ad-hoc meetings, document management support).
• Attend enterprise network meetings as needed to represent the Technology / IT function.

• Recommend deviation management improvement strategies across Technology/IT.
• Collaborate with Quality, IT application, cybersecurity, and business teams to supervise and resolve identified risks and vulnerabilities associated with deviations and CAPA’s.
• Assist in conducting CAPA applicability assessments, time studies, and related initiatives to identify impacts and improvement opportunities in IT systems, processes, and policies.
• Supervise, monitor, and report on the efficiency of existing GxP records, trends, and recommend improvements as needed.

• Ensure compliance with relevant industry standards and regulatory requirements (e.g., GxP, GDPR, SOX, NIST).
• Assist in proactive measures to facilitate compliance, such as collaborating with collaborators to initiate periodic reviews
• Assist in the preparation for audits and inspections by internal and external parties, providing documentation and evidence of IT GxP deviation management practices.
• Support the development and implementation of IT governance, risk, and compliance frameworks and continuous improvements.

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• 5+ years of experience in IT GxP deviation management, IT quality management, IT auditing, or information security.
• Hands-on experience with deviation management tools and associated frameworks (e.g., ISO 27001, NIST, COBIT).
• Master’s degree and 4 to 6 years of information technology, Cybersecurity, Risk Management, or a related field experience OR
• Bachelor’s degree and 6 to 8 years of information technology, Cybersecurity, Risk Management, or a related field experience OR
• Diploma and 10 to 12 years of information technology, Cybersecurity, Risk Management, or a related field experience

Preferred Qualifications:

• Good understanding of GxP deviation management, document management, IT infrastructure, systems, and security standard methodologies.
• Ability to assess technical and business risk related to information systems.
• Excellent problem-solving, analytical, and communication skills.
• Ability to communicate complex GxP and risk concepts to non-technical collaborators.
• Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX).

• Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, enterprise change management tools, and security incident management tools.
• Experience with security controls related to networks, databases, and cloud environments.

• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 with 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 an accommodation.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.