Req ID #: 229721
Wilmington, MA, US
1st
Full time
For 75 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 have an exciting opportunity for a Specialist, Global Computer Validation Quality Assurance for Corporate located remotely.
Provide quality assurance monitoring and audits of Charles River computer validation projects globally to assure compliance with applicable regulations, corporate policies, and procedures. Review and approve global technology processes and assist in periodic assessments of globally controlled IT regulated activities.

Essential responsibilities:

• Communicate all identified compliance and quality risks to his/her supervisor.
• Provide quality assurance monitoring of projects to assure regulatory compliance of complex and critical computer systems at designated sites, assisting with the development, review and approval of validation deliverables (e.g., validation plans, test results, and summary reports).
• Provide compliance support to QA, operations, and project teams on multisite and global computer systems, assisting with the development, review and approval of system validation and maintenance lifecycle deliverables in compliance with company policies and procedures.
• Develop, review and approve global policies, standards and procedures.
• Assist in the development and maintenance of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies.
• Conduct audits of systems, vendors, information technology and processes for compliance with regulations and company procedures.
• Work directly with the various staff and management on global internal audit-related activities including planning and oversight of IT internal and external audits, walkthroughs, testing, documentation of findings, issue remediation, follow-up, etc.
• Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements.
• Provide compliance guidance to operational personnel on regulatory requirements for computerized system validation and data integrity.
• Assist in conducting data integrity risk assessments and consult in risk mitigation strategies.

The pay range for this position is between $70,000.00 and $77,000.00 annually . Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

JOB QUALIFICATIONS

The following are minimum requirement related to the Specialist, Global Computer Validation Quality Assurance position.

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific discipline and/or computer related field.
• Experience: 5 or more years or related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of computer validation requirements in government regulations including FDA 21 CFR Parts 11, 58, 211, and 820, OECDs, data integrity guidance and related multinational industry standards and requirements.
• Certification/Licensure: None
• Other: Must be able to perform effectively as a team member, maintain a positive work atmosphere, communicate effectively, and interact in a professional manner with management, coworkers, and sponsors. Skill requirements include foresight, analysis and logic, systematic and orderly planning, and attention to detail.

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 RiverCharles 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 over 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.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

• Communicate all identified compliance and quality risks to his/her supervisor.
• Provide quality assurance monitoring of projects to assure regulatory compliance of complex and critical computer systems at designated sites, assisting with the development, review and approval of validation deliverables (e.g., validation plans, test results, and summary reports).
• Provide compliance support to QA, operations, and project teams on multisite and global computer systems, assisting with the development, review and approval of system validation and maintenance lifecycle deliverables in compliance with company policies and procedures.
• Develop, review and approve global policies, standards and procedures.
• Assist in the development and maintenance of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies.
• Conduct audits of systems, vendors, information technology and processes for compliance with regulations and company procedures.
• Work directly with the various staff and management on global internal audit-related activities including planning and oversight of IT internal and external audits, walkthroughs, testing, documentation of findings, issue remediation, follow-up, etc.
• Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements.
• Provide compliance guidance to operational personnel on regulatory requirements for computerized system validation and data integrity.
• Assist in conducting data integrity risk assessments and consult in risk mitigation strategies