IT Compliance Specialist

At Charles River, we are passionate about improving the quality of people's lives. Our mission is to create healthier lives for millions of patients and their families. As a leading contract research organization, we provide a diverse portfolio of discovery and safety assessment services to support our clients from target identification through preclinical development.

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.

Job Summary

As an 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. You will 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.

Key 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.
• Compiles and reports performance metrics from datasets and/or applications for role to manager.
• Identify process and control improvements, automation, and consolidation opportunities.
• Research and recommend supporting tools and technologies to support or improve controls.

Qualifications

• Education: 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). 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. We provide a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities.

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.