Senior IT Compliance Specialist

Job title: Senior IT Compliance Specialist

Company: Charles River Laboratories

Job description: For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Summary

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.

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 and document management of Global IT Standard Operating Procedures (SOPs) and Deviations
• Assist with coordination of internal, client, and regulator inspections at Global IT data centers
• 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
• Perform all other related duties as assigned

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in Computer Science, Information Systems Management, or related field.
• Experience: 7 years related experience in IT related Quality Assurance. Minimum 2 years compliance experience with GLP/GMP regulations.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Other:

• Comprehensive knowledge of regulations related to GMP and GLP
• 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;
• Self-starter; adaptable to change
• Ability to manage multiple priorities, projects, deliverables, and stakeholders
• Excellent interpersonal skills, presentation skills, and verbal I written communication skills

Expected salary:

Location: Laval, QC

Job date: Sat, 17 Apr 2021 22:56:43 GMT