IT Compliance Specialist

2 weeks ago


Papworth Everard, Cambridgeshire, United Kingdom Charles River Full time

Job Summary


As a key member of the Global Technology group at Charles River, the IT Compliance Analyst plays a critical role in ensuring our IT practices align with global regulations and industry standards. This dedicated professional will serve as the subject matter expert for IT compliance, collaborating with IT Management, Global Quality, and internal and external auditors to address audit and compliance expectations, operating efficiency goals, and business objectives.


Key Responsibilities



  • Develop and implement effective processes, procedures, and controls to ensure compliance with regulations such as US FDA GxP and similar international regulations.
  • Assist with the authoring and document management of Global IT Standard Operating Procedures (SOPs) and Deviations.
  • Manage training programs and records for Global IT staff, ensuring all personnel are up-to-date on compliance requirements.
  • Coordinate internal, client, and regulator inspections, audits, and reporting activities.
  • Identify and implement remediation of internal control gaps and deficiencies.
  • Provide daily administration and technical/functional support for IT Compliance, TrustArc, DataSite, and Loopio platforms, including user administration, profiles, and roles, workflows, and platform customization.
  • Compile and report performance metrics from datasets and/or applications for the role to manager.
  • Research and recommend tools and technologies to support or improve controls.
  • Perform other work assignments given by manager, to the quality required and in the agreed time.

Qualifications



  • Bachelor's degree (B.A./B.S.) or equivalent in Computer Science, Information Systems Management, or related field.
  • Experience in IT Support & related Quality Assurance.
  • Experience in SDLC; Change Management; Training Management.
  • Familiarity of regulations applicable to IT Service Delivery - Global Applications (ITIL, GxP, GDPR).

About Charles River


Charles River is an early-stage contract research organization (CRO) dedicated to improving the quality of people's lives. With over 20,000 employees across 110 facilities in 20 countries, we provide a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support our clients from target identification through preclinical development. Our mission, excellent science, and strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.


Why Charles River


We recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.


About Corporate Functions


The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards.


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