Job Summary

This position reports to the Site Head of Quality, and the person filling this role is responsible for partnering with functional stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initaitives, Operations, functional support organizations, and execution of GMP activities at the Rockville site. This position interacts regularly with key clients as well as interfaces with regulatory agencies during inspections.  This position is responsible for overseeing all quality operations functions, including execution of environmental monitoring, sterility assurance, routine QC testing and deliver to stability testing, and the overall oversight and operation of the Quality Testing Lab.  This position will also oversee timely batch lot disposition, timely investigation and CAPA related to deviations.  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 production processes. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•    Conceptualize, create and implement all Quality Production strategy and tactics for the site, in collaboration with other Quality, Operations, and Functional groups.
•    Develop and oversee the quality on the floor operations, including timely identification of deviations and corrective actions, and  line clearances.    
•    Develop and execute training and Management briefings at any technical or compliance level required on updates and regulatory requirements.
•    Regularly communicate with clients and participate in the Client quality reviews and other steering committees as required.
•    Guide Environmental Monitoring and Quality Lab Manager in identifying and maintaining services and timeframes to all internal and external clients.
•    Develop metrics and dashboard to show the effect Quality is having on the floor and in Production.   
•    Supervise the QA 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 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 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
•    Minimum 5 years experience with Environmental Monitoring and Assay Testing
•    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 people 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.
•    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

Compensation Data

The pay range for this position is $140,000 – $165,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.