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IT Infrastructure Compliance Manager
Hours: Full Time £40k - £50k D.O.E
The IT Infrastructure & Compliance Manager is a new role that is part of our planned IT Compliance organization to support the IT team to ensure compliance with GxP, Data, Privacy, and Financial requirements.
You'll be responsible for ensuring all IT Infrastructure, platforms, and tools are in compliance according to their risk profile and the requirements of the business.
You'll be providing advice and participation in project team activities with respect to the qualification of new and existing computerised business applications and other software systems.
You will provide direction compliance leadership for global and local projects, as well as prepare plans, test protocols and reports in line with GxP
You'll be able to apply sound problem solving techniques to assure mutually agreeable solutions whilst maintaining regulatory compliance and have near autonomy in deciding the best and most appropriate approaches to the work.
* Review existing Infrastructure Qualification program and drive improvements
* Keep governing SOPs - current and relevant
* Support the maintenance and ongoing development of SOPs to ensure compliance to relevant regulations
* Ensures that infrastructure-related corrective and preventative actions are established, tracked, and trended and that root cause issues are addressed in a timely fashion
* Ensure a scientific and risk managed approach to infrastructure qualification is taken
* Provides quality oversight to ensure fitness for purpose of IT infrastructure, platforms, and IT Tools.
* Support audits and inspections as required
* Accountable for the timely remediation of all qualification related audit findings related to IT infrastructure, platforms, and IT Tools.
* Conduct internal assessments according to procedure
* Review/Approval of infrastructure lifecycle documentation
* View and approve vendor supplied documentation
* Guide and approve IT infrastructure Change Controls
* Bachelor's degree or equivalent experience ie educational concentration in science or computer-based discipline (e.g., Computer Science, Information Systems)
* 7+ years of demonstrated knowledge and application related to IT infrastructure governed by GxP regulations and with GAMP 5 experience.
* 5+ years IT Quality and /or GxP Computer Qualification
* Experience with, change controls, life cycle management, and operations in regulated environments.
Essential Competencies, Skills & Attributes:
* Experience operating with outsourced service providers in an international context
* Proficient in ITIL service management methodologies
* Understanding of the public/private cloud technologies and their qualification approach
* Working knowledge of external control audits
* Working knowledge of GAMP 5 Systems Development Life Cycle methodology.
* Working knowledge of quality and risk management tools, CAPA and deviation management, documentation management, training, change control and qualification.
* Working understanding of virtual technologies and qualifying them
* Demonstrated ability to think strategically and to work collaboratively using risk-based, proactive approaches to operations problem-solving
* Leadership skills and the ability to manage and work with individuals in a matrixed environment.
* Excellent interpersonal skills and the ability to operate and influence key stakeholders in a dynamic and pressured environment.
* Excellent analytical, written and oral communication skills for both strategic and tactical messages with the ability to translate technical terms and GxP computerized system risks into QA business language with sound rationale.
* Strong project management skills
* Demonstrated Collaboration
* Positive and energetic
Ref: FB- MDNHD
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