United States
Mobile Technologies Inc.
Neurona Therapeutics
Sr. Manager, IT Compliance
United States
South San Francisco, California, United States
About the opportunity
SENIOR MANAGER, IT COMPLIANCE
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.
Location: South San Francisco, CA, 94080
Job Type: Full Time
Work Type: On-Site
Alert
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 cisa.gov/be-cyber-smart/report-incident to learn how to report it.
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.
Required Qualifications
- 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
Preferred Qualifications
- Experience in a clinical-stage biotechnology or pharma environment; cell and gene therapy experience a plus.
- Experience qualifying and auditing SaaS/cloud vendors and MSPs against SDLC standards.
- Familiarity with GAMP 5 risk-based validation methodology.
- Certifications such as ASQ CQA, RAC, or CSV-specific credentials.
- Experience validating security tooling (SIEM, EDR, IAM) within a GxP-computerized systems framework — useful for close coordination with an IT Security counterpart.
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