Site Quality Head

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.

All potential applicants are encouraged to scroll through and read the complete job description before applying.

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

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.

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, or 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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Salary : $230,000 - $250,000