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.