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 Summary
As an IT Compliance Analyst you will Provide subject matter expertise 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 : It’s a remote based role in India with some occasional travel as per business requirements.
Essential Duties And Responsibilities:
Assist IT System Owners in executing computer system validation, qualification, and change control activities (planning, documentation, testing, etc..) for regulated Global IT systems under GLP/GMP standards
• Assist with the authoring compliance documents such as (Policies, Procedures, SOPs, CAPAs, deviations and periodic reviews)
• Assist with coordination and execution of internal, client, and regulatory audits/inspections and Questionnaires, including pre and post activities.
• Lead/Actively participate in vendor qualification and management program.
• Assist with management of training program and record management for Global IT staff
• Identify process and control improvements I automation I consolidation opportunities
• Lead/Actively participate in effective and efficient design, implementation, and testing events for IT
• Contribute to IT risk and controls program strategy, design, development, implementation, and communication
• Participate in execution of internal audits and reporting
• 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.
• Fluency working with Smartsheet and/or Excel.
• Perform all other related duties as assigned.
Job 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.
• Very strong experience in IT related Quality Assurance and quality systems principles (training documentation, change control, audits)
• An expert with hands on experience in IT compliance and a comprehensive understanding of GLP/GMP regulations.
• Very strong GxP experience in the life science or Pharma or Biotech industry.
Others:
• Experience with computer system validation (CSV) in a pharmaceutical/life science setting
• Knowledge and experience in Governance, Risk, and Control (GRC) frameworks, approaches, tools, methodologies (i.e., GAMP 5, ISO 2700(X), ITIL, etc.)
• Experience in SDLC; Change Management; Configuration Management.
• Ability to manage multiple priorities, projects, deliverables, and stakeholders
• Excellent interpersonal skills, presentation skills, and verbal I written communication skills.
• Experience supporting SOX and/ or Data Privacy a plus
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 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. 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
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.
