Quality Systems Project Manager

Quality Systems Project Manager Req ID #:  214003 Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

  Job Summary

This position reports to the Director, Quality Systems and will be responsible for supporting the development, implementation and improvement of current and future Quality Management Systems including Document Control, Change Control, Nonconformance Investigations, CAPA, Training, Supplier Quality, Internal Auditing, Quality Management Review (QMR), and Risk Management.  Managing communication for client projects, including CAPAs, Change Controls, Deviations, technical details, and compliance deliverables necessary to meet project timelines and expectations. Manage the implementation, maintenance, and improvement of Quality Systems based on established direction and priorities. Lead, support, and perform activities in the following areas: Internal Quality Audits, Supplier Audits, CAPA, Nonconformance Investigations, Quality Management Reviews, Document Control, Change Control, Risk Management, and Training. Compile and report key performance indicators, metrics and compliance status of Quality Systems for Management Review. Provide exceptional customer service to CRL’s internal and external customers in all assigned tasks and foster a GMP compliance culture. Maintain a continuous improvement program. Assist with Training on GDP/GMP and other quality-related topics. Ensure compliance to quality policies, procedures, and governing regulations. Represent Quality Department during regulatory inspections, client audits, and various cross-functional meetings, as needed. Participate in relevant project meetings with clients and internal departments. Field and respond to customer quality related requests, inquiries, and complaints; able to identify when escalation or help is needed and can engage the appropriate colleagues. Assist in the coordination and facilitation of escalation meetings with the Director of Quality Systems, steering committees, and Quality reviews. Job Qualifications Minimum BS/BA Life Sciences or related field. Minimum 3-5 years of experience in a biologics, pharmaceutical, medical device, or related industry. Ability to work independently and in a group on a variety of projects. Ability to maintain a high degree of accuracy and attention to detail. Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively. Ability to monitor and report on assigned tasks, goals, and objectives. Competency with electronic document managements systems, preferably MasterControl. Proficiency in Microsoft Office (Word, Excel, Outlook, etc.).

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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 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.

Nearest Major Market: Memphis

Job Segment: Pharmaceutical, Project Manager, Document Control, Laboratory, CAPA, Science, Technology, Administrative, Management