Senior IT Compliance Specialist- REMOTE

Senior IT Compliance Specialist- REMOTE Req ID #:  109271 Location: 

US Baltimore, MD, US, 21224 Charlotte, NC, US, 28203 Chicago, IL, US, 60654 Raleigh, NC, US, 27610 Memphis, TN, US, 38104 Cleveland, OH, US, 44128 Ashland, OH, US, 44805 Mattawan, MI, US, 49071 Reno, NV, US, 89511 Detroit, MI, US, 48201 Shrewsbury, MA, US, 01545 Roanoke, IL, US, 61561 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 GXP 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 Job Qualifications QUALIFICATIONS:

•    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 GXP 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 GXP 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 and Configuration Management Familiar with writing SOP policies and auditing process 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 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 17,000 employees within 90 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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