Manager Validation Job at Charles River Laboratories
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
- Manage team with the development of departmental documents and validation of GxP
equipment, systems and assist as needed
- Ensures employees are adequately trained and makes appropriate staff recommendation
- Keep current with regulatory developments, including GxP, 21 CFR Part 11, EU Annex 11, GAMP, ICH, USP and risk management, corporate policies and procedures, etc
- Ensures consistent interpretation and implementation of regulatory controls to all projects, regardless of size, scope or location
- Responsible for the timely execution of all systems implementations, software validations and instruments qualifications, in a compliant manner and in alignment with established quality and regulatory requirements.
- Write, review and approve user requirement specifications, risk assessments, operation, SOPs related to computerized systems for compliance to regulatory requirements.
- Approve departmental documents as needed or in support of leadership
- Assist or manage implementation of critical GxP equipment/systems
- Assist in managing departmental objectives, creating direction and vision
- Participates and supports regulatory audits
- Represent the department in meetings, decision making and overall representation
Job Qualifications
- Bachelor's degree in related Science/Engineering or equivalent experience considered required
- Master’s degree in related discipline preferred
- 3-5 years' experience in a GxP environment, validation experience required
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
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