Sr. Manager, IT Compliance

We are hiring! Our ideal candidates are self-motivated individuals who have clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and build an exciting, science-driven company. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Position:Sr. Manager, IT Compliance

Location: South San Francisco, CA

Job :384

# of Openings:1

Job Type: Full Time

Work Type: On-Site

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.

• 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 life cycles (SDLC) meet regulatory standards before procurement.

• 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).

• 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.

• 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.

• 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, Master Control, 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…