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IT Compliance Specialist

Req ID #:  38729
Location: 

Wilmington, MA, US, 01887

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

We are seeking an experienced IT Specialist II - Compliance for our site located in Wilmginton, MA
 

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 FDA Part 11 and similar international regulations.
 

  • Assist IT System Owners in executing validation 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.
  • Oversee IT GLP/GMP training program and record management for Global IT staff.
  • Identify process and control improvements I automation I consolidation opportunities.
  • Ensure effective and efficient control design, implementation, and testing procedures.
  • Contribute to IT risk and controls program strategy, design, development, implementation, and communication.


The following are minimum requirements related to the IT Specialist II - Compliance position.

  • Education: Bachelor's degree (B.A./B.S.) or equivalent in Computer Science, Information Systems Management, or related field.
  • Experience: 6-9 years related experience in IT related Quality, Audit, and/or Controls Assurance; Minimum 3 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.
  • Certification/Licensure:  Certified Information Systems Auditor (CISA) or equivalent professional certification (e.g., CRISC, CSOXP, CSOXM) desired.
  • Other:
    • Comprehensive knowledge of regulations related to GMP and GLP
    • Experience with computer system validation (CSV) in a pharmaceutical/life sciences setting
    • Knowledge and experience in Governance, Risk, and Control (GRC) frameworks, approaches, tools, methodologies (i.e., GAMP 5, ISO 2700(X), 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
       


 

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 13,000 employees within 80 facilities in 23 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 80% of the drugs approved by the FDA in 2017.

 

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

 

Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet


Nearest Major Market: Boston

Job Segment: Biotech, Information Systems, Pharmaceutical, Laboratory, Science, Technology, Research