IT GXP Systems Analyst

Skills

1. Serve as the primary point of contact for IT-related GxP matters ensuring compliance with regulatory guidelines and requirements. 2. Conduct internal and external audits to assess GxP compliance in IT systems processes and documentation. 3. Identify areas of risk and non-compliance and propose corrective and preventive actions to address them. 4. Collaborate with cross-functional teams to develop and maintain GxP-related documentation including policies procedures and work instructions. 5. Provide expert advice and guidance on IT infrastructure validation and system life cycle management within the GxP environment. 6. Monitor and evaluate IT systems and processes to ensure they meet GxP standards and regulations. 7. Stay up-to-date with industry trends regulatory changes and best practices related to IT GxP compliance. 8. Participate in regulatory inspections and audits addressing any IT-related queries and findings. 9. Collaborate with vendors and third-party service providers to ensure their compliance with GxP regulations and standards.

Description

AbbVie is seeking an energetic, self-motivated IT GxP SME with Audit Experience to join the Third-Party Risk Management (TPRM) team within the Information Security & Risk Management (ISRM) function of Business Technology Solutions performing remote/onsite desktop audits. The TPRM team is a dedicated group of professionals whose mission is to provide value-add, independent stewardship of AbbVie’s third-party management practices enabling Abbvie business owners to manage third party risk.



The IT GxP SME will play a key role in maturing AbbVie’s TPRM program and providing expert audit guidance and support in IT systems and processes within the GxP (Good Practice) environment. This role involves ensuring compliance with regulatory requirements, conducting audits, and identifying areas for improvement to maintain quality and efficiency. The IT GxP SME collaborates with various stakeholders, including IT teams, quality assurance, regulatory affairs, and auditors, to ensure the successful implementation and maintenance of GxP standards.

Responsibilities

• 1. Bachelor's Degree in Risk Management, computer science, information technology, or a related field. A master's degree is preferred.
• 2. Extensive experience (5+ years) working in IT roles within a GxP-regulated environment, such as pharmaceuticals, biotechnology, medical devices, or healthcare, including experience in risk, compliance, and audit; most preferred with experience in pharmaceutical industry.
• 3. Strong knowledge of GxP regulations (e.g., FDA 21 CFR Part 11, EU GMP Annex 11) and their application to IT systems and processes.
• 4. Proven experience in conducting GxP audits and inspections, including interpreting and addressing findings and observations.
• 5. In-depth understanding of IT infrastructure, third party risk management, supplier life cycle, and validation processes within the GxP environment.
• 6. Excellent analytical and problem-solving skills, with the ability to assess risks and propose effective solutions.
• 7. Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders.
• 8. Detail-oriented with a high level of accuracy in documentation and data analysis.
• 9. Professional certifications related to GxP compliance and auditing (e.g., ASQ CQA) are highly desirable.
• 10. Ability to work independently and manage multiple projects simultaneously while meeting deadlines.