Director Quality Assurance Operations

Req ID #:  217075

Memphis, TN, US, 38104 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.

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 quality operations 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 interacts regularly with key clients.  This position is responsible to oversee all quality operations functions, including lot disposition, deviation and CAPA disposition, quality on the floor activities, hosting client and regulatory audits including responses and continuous improvements.  This position will provide the appropriate leadership and strategic direction to operate and maintain a regulatory compliance position in support of existing and new cellular therapy production. Serves as a site host during regulatory inspections and regularly communicates with all local, national, and international regulatory agencies.   This position will also oversee timely batch lot disposition, timely investigation and CAPA related to deviations.  This position will also oversee the development and presentation of all quality Management Review metrics and site risk assessment.   


Conceptualize, create and develop all Quality Operations strategy and tactics for the Memphis Manufacturing Operations, in collaboration with other Quality Assurance groups and Manufacturing.

Develop and oversee the quality on the floor operations, including timely identification of deviations and corrective actions, timely lot disposition, line clearances and in-place continuous audits.    

Advise the Head of Quality of necessary regulatory changes and updates to regulatory and compliance approaches.  

Develop and execute training and Management briefings at any technical or compliance level required on updates and regulatory requirements for Cell and Gene Therapy manufacturing and controls.

Manage the implementation, maintenance, and improvement of all lot disposition functions.

Regularly communicate with clients and participate in the Client quality reviews and other steering committees as required.

Act as the acting Head of Quality as needed or assigned. 

Develop metrics and run the Quality Management Review process for clients and Memphis Operations.   

Review and comment on any CMC regulatory filings for clients.

Review/ approve the Firm’s “drug master file.”

Review/ approve/ update the Firm’s “site master file.”

Perform any client label approvals.

Coordinate and publish any correspondence with Regulatory Agencies. 

Represent Quality department during regulatory inspections, client audits, and various cross-functional meetings, as needed.

Participate in the Company GMP Training Programs, including new employee orientation and periodic GMP retraining and selected topics.

Oversee the Company quality management system deployment and monitoring including client metrics, effective deviation investigation and effective CAPA.

Oversee the Visual Inspection Program and Packaging Inspection Manufacturing

Oversee the Incoming Receipt and Inspection program for components and raw materials

Oversee the writing update of most GMP Company documents, including batch record development and deployment, label generation, work orders, validation protocols/ reports and standard operating procedure updates.   

Demonstrate an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee.

Job Qualifications


  • 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, but not a require per say, if 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
  • Demonstrated management and collaboration skills
  • Outstanding verbal and written communication skills.  
  • Complete competency with electronic document managements systems and other information management system

Compensation Data

The pay range for this position is $200,000/yr - $220,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.


Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.

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 [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.


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Nearest Major Market: Memphis

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