What are the responsibilities and job description for the Senior Manager, QA Validation position at ElevateBio?
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
ElevateBio is looking for a Sr. Manager to provide QA oversight and strategy for the BaseCamp Pittsburgh Commissioning, Qualification, and Validation activities. In this role the Sr. Manager will be responsible for managing cGMP compliance from a Quality Assurance prospective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position with support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.
Here’s What You’ll Do
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
ElevateBio is looking for a Sr. Manager to provide QA oversight and strategy for the BaseCamp Pittsburgh Commissioning, Qualification, and Validation activities. In this role the Sr. Manager will be responsible for managing cGMP compliance from a Quality Assurance prospective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position with support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.
Here’s What You’ll Do
- Provide QA oversight of commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories.
- Provide QA oversight and support for periodic review and requalification activities.
- Change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state.
- Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
- Manage/complete Quality Risk Assessments (QRA) for facility and engineering activities.
- Support use of the Kneat Paperless Validation system at the BaseCamp Pittsburgh facility.
- Bachelor’s degree in engineering, life sciences or related field with 7 years of validation and/or quality assurance experience
- Strong knowledge of 21 CFR, ICH, EU regulations
- Prior experience in Cell and Gene Therapy manufacturing a plus.
- Prior management experience a plus.
- Experience in new facility commissioning and qualification preferred.
- Experience with Kneat paperless validation system desired.
- Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS)
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
- A team player, who listens effectively and invites response and discussion.
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.
