ElevateBio
Director, Quality Assurance Operations
ElevateBio, Waltham, Massachusetts, United States, 02254
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the 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 Role:
The Director of QA Operations is responsible for quality assurance oversight of the daily operational activities for the manufacturing and testing of the 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. This individual will implement and continuously improve policies, standards, procedures, practices and systems to ensure manufacturing operations are compliant with global cGMP regulations. The incumbent manages the team responsible for providing day-to-day Quality oversight of clinical manufacturing operations, including QA review and approval of Batch Records, Deviations, Laboratory Investigations, Lot Disposition, and providing on-the-manufacturing-floor QA support.
Here's What You'll Do:
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, bringing a strong compliance and quality mindset to a complex manufacturing environment.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 talentDevelop, monitor and improve Quality policies, procedures and processes to meet cGMP regulatory guidance and the growing needs of the organizationFoster a quality mindset by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisionsLead and manage complex projects/teams within corporate objectives and project timelines and participate in cross-functional projects as a Quality subject matter expert.Requirements:
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 requirementsTechnical proficiency & knowledge in use of enterprise electronic data management and execution systems (i.e. ERP, QMS, DMS, LIMS, and MES).
Why Join ElevateBio?
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. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
The Role:
The Director of QA Operations is responsible for quality assurance oversight of the daily operational activities for the manufacturing and testing of the 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. This individual will implement and continuously improve policies, standards, procedures, practices and systems to ensure manufacturing operations are compliant with global cGMP regulations. The incumbent manages the team responsible for providing day-to-day Quality oversight of clinical manufacturing operations, including QA review and approval of Batch Records, Deviations, Laboratory Investigations, Lot Disposition, and providing on-the-manufacturing-floor QA support.
Here's What You'll Do:
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, bringing a strong compliance and quality mindset to a complex manufacturing environment.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 talentDevelop, monitor and improve Quality policies, procedures and processes to meet cGMP regulatory guidance and the growing needs of the organizationFoster a quality mindset by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisionsLead and manage complex projects/teams within corporate objectives and project timelines and participate in cross-functional projects as a Quality subject matter expert.Requirements:
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 requirementsTechnical proficiency & knowledge in use of enterprise electronic data management and execution systems (i.e. ERP, QMS, DMS, LIMS, and MES).
Why Join ElevateBio?
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. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.