IT Compliance Analyst – GXP & SOX

At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.Job SummaryAs a IT Compliance Analyst you will be the subject matter expert to ensure appropriate processes, procedures, and controls are adequately designed, implemented, or remediated to meet audit and compliance expectations, operating efficiency goals, and other business objectives. Collaborate with IT Management, Global Quality, and internal and external auditors on initiatives associated with IT compliance with respect to US FDA GxP and similar international regulations. Additionally, lead the ongoing administration and support of the platforms managed and used by the IT Audit and compliance group. This includes support, configuration, customization, troubleshooting, onboarding activities, maintenance. Please note : Its a remote based role with some occasional travel as per business requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: ⦁ Assist with the authoring and document management of Global IT Standard Operating Procedures (SOPs) and Deviations.⦁ Assist with management of training program and record management for Global IT staff.⦁ Assist with coordination of internal, client, and regulator inspections, audit, and reporting.⦁ Assist in implementing remediation of internal control gaps and deficiencies.⦁ Daily administration and technical/functional support for IT Compliance, TrustArc, DataSite and Loopio platforms and includes day-to-day technical support, user administration, profiles and roles, workflows, platform customization and other routine tasks. Other platforms will be defined as they are acquired for use.⦁ Compiles and reports performance metrics from datasets and/or applications for role to manager.⦁ Identify process and control improvements I automation I consolidation opportunities.⦁ Research and recommend supporting tools and technologies to support or improve controls.⦁ Performs work assignments given by manager, to the quality required and in the agreed time. ⦁ Contributes to ongoing improvements in the value delivered by the Global Technology group. ⦁ Provide high quality customer service experience to all customers both internal and external. QUALIFICATIONS:⦁ Education: Bachelor's degree (B.A./B.S.) or equivalent in Computer Science, Information Systems Management, or related field.⦁ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.⦁ 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)Other:⦁ Experience with process and procedure documentation and improvement planning.⦁ Self-starter; adaptable to change.⦁ Ability to manage multiple priorities, projects, deliverables, and stakeholders.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. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement. About Charles RiverCharles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our 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. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction. For more information, please visit www.criver.com.