Job Summary

The Site Quality Head will be responsible for the conceptualization, development, implementation/ deployment, and improvement of current and future Quality Assurance (QA) and Quality Control (QC) functions at a site level. This person will be responsible for partnering with Global Quality stakeholders for development, implementation, and continuous improvement of Quality standards, programs, and procedures across both QA and QC. At the site level, the person filling this role will be responsible to oversee the Quality organization and performance to key performance indicators (KPI) and key quality indicators (KQI). The incumbent must chair the monthly site Quality Management Review (QMR) and be a required attendee at site governance forums to ensure application of standards and performance is maintained and actions are taken, documented, and completed to ensure compliance to regulatory and industry quality standards. The Site Quality Head is also responsible for the leadership, development, and training of members of the Quality Organization.

Essential Duties and Responsibilities

•    Primary Quality contact for all regulatory interactions with all domestic and world regulatory authorities, including but not limited to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) 
•    Primary client contact for the quality oversight of development and manufacture of programs at the site. This includes ensuring Quality Technical Agreements (QTA) are implemented, maintained, and followed as well as participation in client meetings where quality decision making, or endorsement is required
•    Responsible for all regulatory strategy and compliance at the site 
•    Responsibilities include final decision-making authority on quality matters, including lot rejection and acceptance. 
•    Collaborate with network partners to devise appropriate strategies for quality, regulatory and compliance, and responsible to implement necessary changes to these areas at the site level 
•    Ensure appropriate subject master expertise is maintained 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 collaboration with Global stakeholders for the conceptualization, deployment, implementation, maintenance, and continuous improvement of all Quality Management Systems (QMS) and implement at the site level.
•    Responsible for all QA and QC functions at site level including but not limited to incoming material testing and release oversight, oversight of operations and support functions to ensure successful and compliant operations, lot/ batch disposition, adherence to performance standards for the QMS, for all phases of the product development life cycle, from pre-IND to commercial production 
•    Sponsor all Quality continuous improvement activities, including any remediation efforts to bring facilities, systems, and processes up to current CRL standards. 
•    Provide leadership to and ensure necessary Quality oversight of 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 
•    Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. 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. 
•    Six Sigma Green or Black Belt Certification is preferred.
•    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.

Compensation Data

The pay range for this position is $230,000 to $250,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.