Director of Quality Assurance Operations
4 hours ago
ElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The RoleThe Director of Quality Assurance Operations is responsible for quality assurance oversight of the daily operational activities for the manufacturing and testing of cell and gene therapy products at our BaseCamp facility in Waltham, MA. This role provides leadership to ensure that cGMPs are maintained and product is manufactured at the highest quality.
Key Responsibilities- Lead a team of QA managers and individual contributors to support routine cGMP operations with an effective QA on-the-floor support function for critical cell and gene therapy manufacturing activities.
- Ensure cohesive collaboration across QA Operations and Manufacturing for thorough and timely review of manufacturing records, enabling right-first-time batch record review and on-time batch disposition with a high level of efficiency and quality.
- Interface with internal and external clients regarding Quality Assurance, Product Lifecycle, and continuous improvement topics.
- Collaborate with QA Validation, Manufacturing Science & Technology, Manufacturing, Facilities & Engineering, and QC for the successful technical transfer of manufacturing processes into routine production, leveraging risk management tools to identify operational risks and associated mitigation control strategies.
- Responsible for the management of the cross-functional sterility assurance and contamination control program.
- Participate with other Quality functions and Management for client interactions and communications.
- Establish and communicate performance objectives for QA Operations staff that are consistent with corporate and Quality goals and objectives.
- Provide training, constructive feedback, and a collaborative environment that attracts, develops, and retains the best talent.
- Develop, monitor, and improve Quality policies, procedures, and processes to meet cGMP regulatory guidance and the growing needs of the organization.
- Foster a quality mindset by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions.
- Lead and manage complex projects/teams within corporate objectives and project timelines and participate in cross-functional projects as a Quality subject matter expert.
- Bachelor's degree in a scientific discipline with at least 12 years of experience in a pharmaceutical, biotechnology, or biologics operation, including 7 years of Quality experience.
- Experience with manufacturing of Cell & Gene Therapy Products and with Sterility Assurance Programs preferred.
- Experience in working in a Contract Manufacturing environment preferred.
- Working knowledge and demonstrated ability to apply GMPs across early and late clinical phases.
- Excellent communication skills with a customer service mindset.
- Strong leadership, teamwork, and problem-solving skills.
- Experience leading and training others in root cause investigations, deviations, OOS, and CAPA.
- Strong knowledge with aseptic manufacturing process requirements.
- Technical proficiency and knowledge in use of enterprise electronic data management and execution systems (i.e., ERP, QMS, DMS, LIMS, and MES).
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.
We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission: To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision: We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created, and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.
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