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.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.About Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.About Charles RiverCharles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.Equal Employment OpportunityCharles 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 [email protected]. 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.224914