Sr. IT Compliance Specialist
Charles River Laboratories International Inc (CRL)
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.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
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:
- Act as point of contact for training program and record management for Global IT staff
- 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
- 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: 4 – 6 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.
- 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;
- Experience in training team(s) in the following: LMS, DMS, DTS
- 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
The pay range for this position is $130,000 - $150,000 USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment OpportunityCharles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.