The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
Center for Breakthrough Medicines is seeking a quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The Associate Director of QA Testing Operations will help build scalable QA systems as the organization continues to grow. The role will be responsible for management of the quality system within the organization and oversees all testing laboratory activities and operations including oversight of technical staff. The role also manages site testing operations, related programs, and activities to support the contract manufacturing organization and manufacturing operations. The role supports Testing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.
· Management of test method data review process in support of cell and gene therapy product release as well as testing for client services.
· Analyze test method data to identify trends and key issues, identify and implement plans for resolution.
· Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies, and site procedures.
· Plan objectives and schedule tasks and resources efficiently
· Partner with other business units or departments in support of continuous improvement initiatives
· Author and revise procedures to address gaps or needed improvements to quality systems
· Review the implementation, execution and effectiveness of the quality systems and inspection processes
· Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization
· Oversee all aspects of testing operations within the organization, including but not limited to, QA support on the floor, material release, deviation investigations, CAPAs, change controls, client quality support and SOPs
· Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
· Develop, motivate, and lead teams of cross-functional resources in a matrixed organization with competing priorities.
· Critically review various documentation types to ensure completeness, accuracy and compliance
including but not limited to test methods, change controls, and standard operating procedures
· Provide Quality input for the investigation of OOS results including support on determining investigative testing plans, resampling, and root cause analysis
· Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities
· Interacts and represents The Center for Breakthrough Medicines with all regulatory agencies
· Develop quality systems including a robust and on-going quality improvement system compliant with GMP
· Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance
· Interact with the quality team and internal stakeholders to support the development, testing, and release of manufactured products as needed
· Manage problems of varied scope using a high degree of prudence and risk-based decision making
· Monitor, study performance via key performance indicators to maintain or improve operational efficiencies, while ensuring compliance to GMP regulations
· Ensure test methodologies provide quality of results required and are in full compliance with regulatory requirements, standards, and protocols
Additional duties as assigned