Experience Inc. Jobs

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

The Senior Manager of Quality Systems will be responsible for partnering with global Quality stakeholders for development, implementation, and continuous improvement of Quality Management Systems (paper and electronic) which include but are not limited to Document Control, Deviations, CAPA, Change Control, and Quality Management Review (QMR) to serve the needs of the contract manufacturing organization. At the site level, the incumbent filling this role will be responsible to oversee the teams responsible for: review and approval of Quality Management System (QMS) tracking and trending reports, scheduling and adherence of Quality Management System governance boards, supplying raw data and metrics to the various governance boards, ensuring compliance to Quality Management Systems across all functions at the site, as well as the leadership and development of members of the Quality Systems Organization.

• Manage and oversee the continuously improvement of current Quality Systems as defined in the Quality Improvement Plan

• Evaluate the Quality needs of incoming clients by assessing the prospective clients Quality Systems, while developing a plan with key milestones to integrate their processes into the Charles River Quality Systems

• Build cross-functional relationships with relevant internal and external stakeholders necessary to ensure sustained delivery of Quality System performance and KPIs

• Support the selection and implementation of electronic Quality systems for use at the Memphis site and consistent application across network

• Maintain knowledge of policies and procedures concerning Quality Systems and operational philosophies.

• Lead and develop a team of Quality employees with varying levels of experience

• Perform all other related duties as assigned

Job Qualifications

• Bachelors degree in science or engineering

• 5 or more years of experience in Quality, Manufacturing, Engineering or related field

• Direct experience supporting customer audits or Regulatory inspections

• Minimum 2 years of management exerperience in in a manufacturing environment

• Knowledge of current GxP regulations of QMS requirements, current industry best practices in the area of biologics or cell and gene therapy manufacturing is strongly preferred

• Previous experience in the deployment, validation, and/or use ofeElectronic Quality Systems for document control, deviation management, CAPA and change control

• Proficient in computer system use, including but not limited to Microsoft Office Suite and QMS software.

• Strong analytical, problem-solving, and project management skills.

• Good leadership/interpersonal/communication/influencing/negotiation skills.

The pay range for this position is $150,000 - $160,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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.

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 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 supported the development of 86% of the drugs approved by the FDA in 2021.

Equal Employment Opportunity

Charles 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 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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