Sr. Manager, IT Compliance
Neurona Therapeutics
Summary
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 IT team.
Job description
Key Responsibilities
Core GxP Lifecycle and CSV
- Lifecycle Validation Ownership: Authors, reviews, and executes the entire validation lifecycle (Validation Plans, URS, IQ/OQ/PQ, and Validation Summary Reports) for all GxP-impacted systems.
- Periodic System Reviews: Conducts mandatory, routine compliance reviews of active validated systems to ensure they maintain their validated state throughout their operational lifespan.
- Vendor Qualification: Audits and qualifies cloud software (SaaS) vendors and the MSP to ensure their software development lifecycles (SDLC) meet regulatory standards before procurement.
Regulatory Risk Mitigation and Audit Defense
- Audit Front-Facing Lead: Serves as the primary IT subject matter expert (SME) during regulatory inspections (e.g., FDA, EMA) and partner audits, defending the compliance status of IT infrastructure.
- Data Integrity Governance: Establishes and enforces policies aligned with ALCOA+ standards to guarantee that all electronic records are attributable, legible, contemporaneous, original, and accurate.
- Deviation and CAPA Management: Leads formal investigations into IT compliance deviations, authors technical root-cause analyses, and implements Corrective and Preventive Actions (CAPAs).
Technical Release, Gatekeeping and Governance
- Change Control Board (CCB) Authority: Serves as the final compliance sign-off for IT changes, ensuring the MSP and internal IT Security teams do not deploy updates that break validated baselines.
- IT SOP Architecture: Drafts, revises, and maintains IT-specific Standard Operating Procedures (SOPs) to keep pace with evolving international regulatory expectations.
- Release Velocity Acceleration: Removes the validation bottleneck by providing dedicated internal bandwidth to validate new systems, allowing the business to deploy new laboratory, manufacturing, or clinical tools without regulatory delays.
Cross-Functional Compliance Partnership
- QA/Quality Systems Alignment: Partners with Quality to ensure IT compliance documentation (validation packages, deviations, CAPAs) integrates cleanly with the broader eQMS and inspection-readiness posture.
- Training & Competency Oversight: Ensures IT and MSP staff working on GxP systems maintain current training records and demonstrated competency on relevant SOPs.
- Metrics & Inspection Readiness: Maintains a living inspection-readiness file (validated system inventory, open CAPAs, periodic review status) so audit prep doesn't start from zero.
Requirements
- Bachelor's degree in Computer Science, Life Sciences, Quality, or related field (or equivalent experience).
- 7+ years in IT/computer systems compliance within a GxP-regulated environment (biotech, pharma, or medical device).
- Demonstrated hands-on authorship of validation lifecycle documentation (VP, URS, IQ/OQ/PQ, VSR) for GxP systems.
- Experience leading or directly supporting FDA/EMA inspections or partner audits as an IT SME.
- Working knowledge of 21 CFR Part 11, Annex 11, ALCOA+, and data integrity principles.
- Experience with deviation/CAPA processes and root-cause analysis methodologies (e.g., 5 Whys, fishbone).
- Experience serving on or supporting a Change Control Board, including validated-state impact assessment.
- Strong SOP writing skills and familiarity with document control/eQMS systems (e.g., Veeva, MasterControl, Qualio).
- Excellent communication skills, with the ability to explain technical/compliance risk to auditors and non-technical stakeholders.
- Strong skillset to provide solutions and lead team members – cross-functionally.
- Experience with Microsoft Technologies (e.g. O365, MS Active Directory, etc.), Cloud based storage platforms (e.g. Egnyte, SharePoint Online, Box, etc.)
- Familiar with networks, server, end user architecture compliance – Windows and Mac for supporting lab/R&D/Scientific teams
Company overview
Neurona Therapeutics is a clinical-stage biotechnology company pioneering regenerative cell therapies for neurological disorders. The company specializes in developing allogeneic, off-the-shelf cell therapies derived from human pluripotent stem cells to treat chronic neurological conditions. Neurona's lead program focuses on NRTX-1001, an investigational cell therapy for drug-resistant focal epilepsy, which has shown promising results in early clinical trials. The company's proprietary platform enables the production of specific types of inhibitory interneurons that can restore neural circuit balance in the brain. Founded by leading neuroscientists, Neurona combines deep expertise in stem cell biology, neuroscience, and clinical development to address unmet medical needs in epilepsy, Alzheimer's disease, and other neurological disorders. The company's innovative approach represents a paradigm shift in treating chronic neurological conditions through regenerative medicine rather than symptom management alone.