Director, QA Systems

Overview

Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Neurona Therapeutics is seeking an exceptional candidate to join our Quality Assurance (QA) team. Our ideal candidate is a self-motivated individual who has a passion for QA and can thrive in a fast-paced dynamic environment.

• 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, GxP, 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

• 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

Recruitment Fraud Notice We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.
If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://(Use the "Apply for this Job" box below). to learn how to report it.