Neurona Therapeutics · 2 hours ago
Manager, Quality Assurance
South San Francisco, CA
Full-time
Onsite
Senior Level
$130K/yr - $150K/yr
5+ years expNeurona 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. The QA Manager will oversee and partner with operational teams to ensure compliance, manage quality activities, and interact cross-functionally to maintain regulatory standards.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Track, analyze, and report QA metrics
Review and approval of facility validation protocols, data, and reports
Review and approval of controlled documents such as protocols, master batch records, specifications, and standard operation procedures
Review and approval of product and raw material specifications
Independent review of executed batch records
Perform raw material release
Review and approval of GMP shipments
Management of temperature excursions
Provide routine on-the-floor Quality oversight to ensure collaborative triage of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems
Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making
Advanced ability to synthesize information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner
Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing
Serve as a subject matter expert supporting others to navigate the Neurona quality management system including but not limited to deviation and CAPA action management, disposition decisions, and batch record management
Implement “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks
Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence
Proactively identify and address quality risks and critical issues, drive mitigations with the aid of cross-functional partners and escalate to senior management as needed
Lead walkthroughs with peers to identify and remediate operational or quality issues
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products
Regularly spend time coaching and mentoring operators while on the manufacturing floor
Work with Regulatory and Clinical Operations supporting Neurona’s clinical trials
Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations
Provide and deliver ongoing training for GMP, GDDP, and Data Integrity
Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures
Other additional QA tasks as directed by QA Management
Qualification
Required
Minimum of 5 years of Quality experience in a GMP-regulated environment (cell therapy, biologics, or sterile pharmaceutical manufacturing strongly preferred)
Strong foundation in the Clinical Supply Process or equivalent pharma/healthcare supply chain process
Must be able to gown for Grade B (ISO 7) manufacturing space
Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines
Strong experience with managing quality systems records, conducting investigations/deviations
In-dept knowledge of cGMP
Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management
Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions
Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience
Ability to work in a fast-paced team environment and lead peers through changing priorities
Ability to think strategically, meet deadlines, and support work prioritization
Ability to negotiate and influence to craft mutually beneficial solutions
Ability to motivate and foster a positive team environment
Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality
Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within budget
Exhibit strong decision-making ability and analytical thinking while maintaining compliance and quality
Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions
Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders
Ability to understand complex problems with multiple datum/variables and articulate practical solutions
Demonstrated experience working with GxP electronic systems such as laboratory information management systems or Quality Management Systems such as TrackWise or Veeva
Ability to lead change in a fast-paced environment with limited information and/or time-constraints
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
Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP, ICH, FDA , etc.)
Actively participate in group and project teamwork, project and process improvements
Ability to support manufacturing processing that occurs during the weekend or at late night/early morning hours
BA/BS degree in Microbiology, Biology, Chemistry, Biochemistry, or related field and at least 5 years of Quality experience in a GMP-regulated environment
Preferred
Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred
Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred
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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