Director Regulatory Affairs & Quality Systems

Director Regulatory Affairs & Quality Systems Req ID #:  185899 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 Sr. Director or Vice President of Quality (Memphis), and will be responsible for the development, implementation and improvement of current and future regulatory affairs functions and regulatory interactions with all manner of national and international regulatory authorities for any client or local concerns relating to the Memphis Manufacturing Operations.   This position is responsible to oversee all internal and external audit programs, including client and regulatory audits, supplier analysis and approvals including responses and continuous improvements.  This position will provide the appropriate leadership and strategic direction to operate and maintain a regulatory and regulatory compliance position in support of existing and new cellular therapy production. Serves as the site Regulatory head and regularly communicates with all local, national and international regulatory agencies.   This position will also oversee departments with  quality system functions including deviations, CAPA’s, batch record issuance, label control and issuance and update of standard operating procedures.  Advise the Head of Quality of necessary regulatory changes and updates to regulatory and compliance approaches.  Oversee the implementation, maintenance, and improvement of all internal and external auditing  functions. Oversee the preparation of any CMC regulatory filings for clients Maintain and update any local, national or international regulatory licenses. Coordinate and publish any correspondence with Regulatory Agencies. Function as the Company Regulatory Head in advising clients of appropriate regulatory solutions based on the stage of product development. Oversee the Memphis Manufacturing Supplier Approval Program. Oversee the Memphis Manufacturing Internal and External Audit program. 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. An advanced degree in the life sciences is preferred, but not essential, based on experience Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry.  15 years  experience is preferred Previous experience in Cell and Gene Therapy is desirable, or other experience in the regulated life sciences  Ability to maintain a high degree of accuracy and attention to detail. Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively. Demonstrated project management skills

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 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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.

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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