Associate II, Quality Systems
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 detail-oriented Quality Systems Specialist to join the Quality Systems & Compliance team. In this role, you will support effective document control processes and training program administration to maintain a strong and sustainable quality framework. You will also provide quality oversight of GxP computerized system validation activities to help ensure systems remain compliant and inspection-ready.
Here’s What You’ll Do:
Document Control & Training
- Support the lifecycle management of GMP-controlled documents in an electronic Document Management System (eDMS), including review, revision, and archiving activities.
- Help maintain document control processes in the Document Control room and within the eDMS to support compliance and audit readiness.
- Assist with Learning Management System (LMS) activities and help maintain accurate GxP training records.
- Support curriculum and training content updates as procedures and systems change, under team guidance.
- Work with team members and stakeholders to help resolve basic document and training-related questions.
Digital Quality
- Provide quality oversight of GxP computerized system validation activities
- Review validation deliverables (plans, risk assessments, test scripts, summary reports) for compliance and completeness
- Apply working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity principles
- Support change control, deviation, and periodic review activities to maintain validated state
- Collaborate with IT and system owners on new system implementations and upgrades
General
- Execute responsibilities independently with limited supervision
- Identify and escalate compliance risks appropriately
- Contribute to continuous improvement of Quality Systems processes
- Support audit and inspection readiness activities
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, Quality, Computer Science, or related technical field (or equivalent experience)
- 2–5 years of experience in a GMP/GxP-regulated environment within Quality Systems, Computerized System Validation, Document Control, or Training
- Experience supporting document control within a Quality Management System
- Experience reviewing or supporting computerized system validation documentation and data integrity assessments
- Working knowledge of data integrity expectations and electronic records requirements
- Familiarity with eQMS, LMS, or other GxP computerized systems (Veeva experience a plus)
- Ability to manage multiple priorities with limited supervision
- Strong attention to detail and effective written and verbal communication skills
Nice to Have
- Experience supporting audits or regulatory inspections
- Experience in a biotech or cell and gene therapy environment
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.
