Information Security GxP Manager

Job Description

Roles & Responsibilities:GxP Governance Leadership

- Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to information security governance, GxP deviation management, document management, audit commitments, and/or policy exception processes.

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
- Lead 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 and Quality Forums as needed to represent the Technology / IT function .
- GxP Deviation Monitoring and Improvements: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.
- Lead and manage 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.
- Governance and Regulatory Support:Ensure compliance with relevant industry standards and regulatory requirements (e.g., GxP, GDPR, SOX, NIST).
- Lead proactive measures to facilitate compliance, such as collaborating with partners to initiate periodic reviews
- Lead 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.
- Support the development and implementation of IT governance, risk, and compliance policies as well as supporting documentation, and their continuous improvements.
- Track and monitor document reviews, and support document owners to ensure timely periodic review completion.

What we expect of youWe are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

- Doctorate degree and 2 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience OR
- Master s degree and 8 to 10 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience OR
- Bachelor s degree and 10 to 14 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience OR
- Diploma and 14 to 18 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience

Preferred Qualifications:

Skills and Competencies:

- Solid understanding of GxP deviation management , controlled 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 partners.
- Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX).

Technical Knowledge:

- Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, controlled document management tools enterprise organisational change tools, and security incident management tools.
- Experience with security controls related to networks, databases, and cloud environments.
- Soft Skills: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, budget, and PI plan successfully
- Ability to manage a team of Information Security experts
- Team oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills

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