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 Sr. Director Quality Assurance will be responsible for the conceptualization, development, implementation/ deployment and improvement of current and future Quality Assurance and regulatory affairs functions. This person is the chief regulatory contact with all national and international regulatory authorities for any client or local concerns relating to the Memphis Manufacturing Operations. This position is also a chief client contact for development and manufacturing and associated quality activities in all matters relating to quality and regulatory compliance and is expected to participate in client negotiations and client interactions, as requested by the CRL business development functions and the Memphis Site Head. This person is expected to have a mastery of all current and modern quality assurance and quality control concepts relating to cell and gene therapy production and associated regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Primary contact for all regulatory interactions with all domestic and world regulatory authorities, including EMA and FDA.

• Responsible for all regulatory strategy for the Memphis Manufacturing Operations.

• Operate as the Head of QA for the Memphis CDMO Operations, with the final and authoritative word on all matters relating to quality, including lot rejection or acceptance.

• Implement necessary regulatory changes and updates to regulatory and compliance approaches.

• Oversee any training and Management briefings needed at any technical level required on updates and regulatory requirements for Cell and Gene Therapy manufacturing and controls.

• Be a known subject master expert in all necessary functions for effective cell and gene therapy manufacturing and control, including contamination control, cross-contamination controls, validation, regulatory compliance and modern facility and system control strategies.

• Responsible for the conceptualization, deployment, implementation, maintenance, and continuous improvement of all Quality Management Systems (QMS).

• Responsible for all Quality Operations functions at Memphis Manufacturing, including lot/ batch disposition and resolution of CAPA and deviations, for all phases of the product development life cycle, from pre-IND to commercial production.

• Lead and direct all Quality continuous improvement activities, including any remediation efforts to bring facilities, systems and processes up to current CRL standards.

• Provide necessary Quality oversight to all production, validation, supply chain and training functions

• Effectively model, demonstrate and live 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.

• Effectively model, demonstrate and live the Charles River core values of Care, Lead, Own, and Collaborate

• Coach and mentor individuals from all parts of the organization. Be a valued resource for the entire CRL organization in all matters related to cell and gene therapy manufacturing.

• Perform all other related duties as assigned.

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. Previous experience in Cell and Gene Therapy is desirable

• 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 systems

• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.

Compensation Data

The pay range for this position is $200,000 to $245,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

The pay range for this position is $200,000 to $245,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

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.

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