About Curate Biosciences
Curate Biosciences’ Curate® Cell Processing System enables virtually lossless cell
processing, radically changing the outcomes and economics landscape of cell therapy.
Designed with both manufacturing and clinical potential at the forefront, the Curate System
enables production of CAR-T and other therapeutic cell therapies beyond today’s limitations.
Curate Biosciences has strong venture financing from Amgen Ventures, Vensana Capital, and
other major healthcare investors and is advancing application of its DCS technology to target
additional cell types, disease states, and workflows.
Job Responsibilities
- Ensure maintenance of the quality system in compliance with FDA, ISO, and other regulations, standards, and internal procedures
- Ensure compliance to the Quality System: Document control, complaint handling, CAPA systems, and training systems
- Manage the preparation of regulatory submissions, including 510k, technical files, and design dossiers
- Manage the Quality Department, including Quality Control and Document Control
- Direct quality planning and risk management activities for new and modified products as a part of the design control process
- Ensure that Design Control procedures are followed; prepare (DHF) Design History File for design control projects.
- Collaborate with external Contract Development and Manufacturing Organizations to obtain necessary documentation for Technical File and DHF
- Review and approve new and modified product labeling and promotional materials for compliance with product specifications and domestic and international labeling and promotional regulations
Qualifications
- BS/BA degree in a science-related or technical field
- Demonstrated knowledge and understanding of Quality System Regulations including 21 CFR 820 & ISO 13485
- Excellent interpersonal, teaming, written and spoken communication skills
- Experience in setting up and maintaining a medical device quality system
- Experience managing Quality relationships with external vendors and suppliers
- Experience in building and leading a team
- Strong communication, problem-solving and motivational skills
Experience: 5-7 years related experience working in a regulated medical device manufacturing environment where compliance was of vital importance
Location: Carlsbad, CA
If you’ve got the experience we’re seeking and are ready to play a pivotal role in a motivated and collaborative team to commercialize transformative technology, we’d like to hear from you.
Please send your CV to [email protected]
Curate Biosciences’ policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
