Quality Systems Manager

Quality Systems Manager Req ID #:  161425 Location: 

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

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 Associate 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

•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 Cognate’s internal and external customers in all assigned tasks and foster a GMP compliance culture.

•Establish and 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. Job Qualifications  

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

• 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. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

About Cognate BioServices

Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.

We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.

Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.

For more information, visit www.cognatebioservices.com 

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, 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

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