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.
The Associate Director of QA Validation will be responsible for. providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments and equipment, as well as building and facility commissioning and qualification), ensuring alignment with industry standards and regulatory guidances. The QA Validation Associate Director will support the execution of validation and qualification protocols and reports as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, the Associate Director of QA Validation will be responsible for the support of facility start-up activities, technical transfers, re-qualifications and routine activities as they pertain to Laboratories, Manufacturing, facilities, Maintenance and Warehouse functions
· Manage the validation program from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, in support of corporate objectives.
· Act as the quality/ validation expert supporting GMPsystems and compliance to industry regulations
· Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs.
· Provide quality oversight and approval of software, equipment/facility qualification.
· Ensure Site Validation Master Plan is followed at site level.
· Provide guidance , oversight and approval of internal and external method qualification, method transfer and method validation project plans, protocols and reports.
· Provide leadership and guidance to staff on qualification/validation matters and compliance to industry regulations: 21 CFR Parts 11, 211, 820, 1271, 600, EU Guidance for Advanced Therapies and Medicinal Products, EU Annex’s, GAMP5 and other industry standards as applicable
· Review and revise SOPs for consistency and compliance with regulatory requirements
· Support regulatory inspections by FDA and foreign regulatory agencies
· Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met.
· Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies.
· Participate in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.
· Lead standardization and harmonization of Standard Operating Procedures.
· Partner with Research and Development and Tech Transfer groups to develop and execute product technical transfer plans to manufacturing facilities.
· Provide support to the initiation, assessment and implementation of internal change controls.
· Apply risk based methodologies in the oversight of validation efforts.
· Provide guidance and direction throughout the Change Control process supporting GxP Systems.
· Participate in cross-functional risk assessments and process parameter classification
· Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports.
· Participate in interdepartmental project/program teams to meet site objectives.
· Provide expertise to technical teams in the implementation of strategies for validation studies.
Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction
· Bachelor’s Degree in science or technical discipline
· A minimum of eight (8) years’ experience in Quality Assurance in the Pharmaceutical, Biotech (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing. (Advanced degrees may be used to reduce required experience.)