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 Center for Breakthrough Medicines QA Department is seeking a QA Validation Manager responsible for providing quality oversight of the validation and qualification activities for manufacturing process, facility, equipment, and systems within a Cell and Gene Therapy manufacturing facility supporting both clinical and commercial programs in a sterile GMP environment. This role will be responsible for reviewing and approving validation/qualification protocols/reports, standard operating procedures, change documents, and reports for projects and maintenance activities.
· Review and approve Validation Documentation including but no limited to: Validation Master Plans, User Requirements, Functional Requirements, FATs, SATs, IQOQPQ, Trace Matrix, Validation Summary Reports and Change Controls.
· Provide quality and compliance oversight for the qualification and validation, of manufacturing, facility, and/or laboratory systems.
· Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation.
· Work in a collaborative team setting with quality counterparts that includes: Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain.
· Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks
· Judgment and problem-solving - able to define decision criteria and determine the most appropriate course of action.
· Planning and organizational skills - able to establish objectives and schedule tasks/resources efficiently.
· Communication skills - strong written communication skills to provide concise and clear documentation
· Partner with a team setting to support continuous improvement initiatives. Support technical and quality investigations to resolve issues
· Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Require minimal direction to complete tasks, knows how to obtain resources and information from established internal contacts; consult with manager for decisions outside established processes
· Bachelor of Science degree or higher education in Engineering or Science
· 5-10 years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements. Two (2) years of experience in a leadership capacity.
· Prior experience in developing, reviewing, and approving validation documentation for equipment, lab systems, utilities, and manufacturing equipment.
· Experience in writing & reviewing SOPs and protocols for accuracy and compliance
· Provide guidance and oversight to Specialist level employees.
· Ability to work closely with multiple disciplines, including: Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain to support validation activities.
· Ability to apply comprehensive knowledge of pharmaceutical cGMPs and quality system controls, procedures, and records to ensure ongoing quality compliance.
· Ability to perform all requirements independently with limited managerial oversight.
· Organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment.
· Superior attention to detail to ensure accuracy of work product.
· Critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.
Advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.