Job Summary

The Director Quality Operations will be responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations, functional support organizations, and execution of GMP activities at the Memphis site. The Director of Quality Operations is responsible to oversee execution and delivery from the following areas of the organization: Drug Product Disposition, Functional Organization Quality Oversight, On The Floor Quality, Raw Material Testing and Release as well as customer facing Quality program leads for each client in the CDMO- Memphis portfolio. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Responsible for Quality oversight of and to support the manufacturing and release of products within the Memphis site. Ensure that these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.

· Build cross-functional relationships with relevant internal and external departments necessary to ensure sustained delivery of Quality System performance and KPIs.

· Prepare Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

· Maintain quality system controls for area of oversight to ensure no critical and major market complaints or audit findings.

· Build improved efficiencies by partnering with functional Leaders and Quality having a consistent presence on the floor.

· Ensure timely sampling, analysis and release of raw materials.

· Take appropriate steps to reduce waste and losses in Quality Operations processes and improve efficiency in ways of working.

· Supervise the Quality Program leads, who are responsible for client communications during the production process, to ensure customer service and program KPIs are met successfully.

· Provide leadership to and ensure necessary Quality oversight to areas within span of control.

· 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

· Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. Be a valued resource for the site in all matters related quality and compliance.

· Perform all other related duties as assigned.
 

Job Qualifications

· Minimum Bachelors degree in 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.

· Experience working in a GMP Biologics environment required.

· Minimum 5 years as a Leader with direct reports

· Complete competency with electronic document managements systems and other information management systems (QMS, ERP, LIMS,MES etc)

· Familiarity preferred with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).

· Ability to maintain a high degree of accuracy and attention to detail.

· Familiarity with basic core QC areas including product/material stability, trending, comparability, qualification/ validation, compendia methods, etc.

· Excellent technical writing skills. Experience in drafting of Standard Operating Procedures (SOPs), protocols, reports, etc.

· Ability to problem solve and trouble shoot as necessary

· Understanding of immunology and the current field of immunotherapies

· Study design, data/ statistical analysis (e.g. use of SigmaPlot, JMP and Excel), reporting results in both written and oral format (presentation)

· Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.

· Outstanding verbal and written communication skills.

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

· Compliance with cGMP/ GLP regulations as well as excellent documentation skills in order to complete paperwork

· Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.

· Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.

· ISO Lead Auditor training, desirable.

· Certified Quality Engineer (ASQ), desirable

· 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

The pay range for this position is $206K – 226,200K.  Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.