Neurona Therapeutics · 2 days ago
Director, QA Systems
South San Francisco, CA
Full-time
Onsite
Director/Executive
$200K/yr - $230K/yr
10+ years expNeurona Therapeutics is a clinical stage biotechnology company focused on the development of neuronal cell-based therapies for intractable neurological diseases. They are seeking a Director of Quality Systems to oversee the development, implementation, and maintenance of the Quality Management System, ensuring the safety, efficacy, and quality of cell therapy products.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Develop, implement, and maintain the Quality Management Systems including Quality Management Review
Develop, design, and execute the electronic record templates for the Quality Systems
Act as the Business System Owner for the eQMS
Trend, analyze, and report on the health of the Quality Systems
Create and update Quality Systems, including but not limited to, Document Control, Training, Change Control, Deviations, CAPA, Supplier Management, Audits, Risk Management, and Management Review
Build, mentor, and lead a high-performing quality team, fostering a culture of accountability and continuous improvement
Ensure Quality Systems alignment with EMA, ICH, and FDA guidance as applicable
Provide guidance to others on the Quality Systems
Author and review protocols, reports, and SOPs for Quality Systems
Perform internal audits as required
Serve as QMS SME during audits and regulatory inspections
Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations
Provide and deliver ongoing training for GMP, GDDP, and Data Integrity
Partner with Manufacturing, QA, Facilities, and Process Development to support training and usage of the eQMS
Identify and support resolution of technical problems
Actively participate in group and project teamwork, project and process improvements
Perform other duties as requested by supervisor/manager to support Quality
Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products
Ensure good working relationships with the site management and all other departments
Manage operational performance using key performance indicators
Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures
Qualification
Required
Minimum of 10 years of Quality experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred)
Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP, ICH, FDA, etc.)
Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines
Strong leadership, mentoring, and team-building abilities
Exceptional technical writing, data analysis, and problem-solving skills
Effective communicator, capable of interacting with cross-functional teams and external auditors
Comfortable in a fast-paced, dynamic environment supporting clinical and commercial manufacturing
Adhere to cGMP policies and procedures, including documentation activities
Able to wear appropriate personal protective equipment
Able to work collaboratively to respond to changing priorities and challenges
Communicate effectively with team members and contribute to a positive and collaborative work environment
Actively participate in group and project teamwork, project and process improvements
BA/BS degree in Microbiology, Biology, Chemistry, or related field and at least 10 years of Quality experience in a GMP-regulated environment
Company
Neurona Therapeutics
Neurona Therapeutics develops cell therapies for neurological disorders, focusing on treatments like NRTX-1001 for epilepsy.
Founded in 2008South San Francisco, California, USA
51-200 employees
H1B Sponsorship
Neurona Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
$440.11MKey Investors
California Institute for Regenerative MedicineSouth Carolina Research AuthorityNational Institutes of Health
2025-06-18Grant· $14M
2025-04-03Series F· $102M
2024-09-10Grant· $3.8M
Leadership Team
James Stutz
Chief Financial Officer / Chief Business Officer
Nadia Agopyan
Senior Vice President
Recent News
Neurona Therapeutics
2025-11-19
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-11-08
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