Sr. Manager, IT Compliance
About The Position
Neurona Therapeutics, a clinical-stage biotechnology company based in South San Francisco focused on neuronal cell-based therapies for intractable neurological diseases, is seeking an exceptional candidate to join its IT team as Sr. Manager, IT Compliance. This on-site, full-time role owns IT compliance for GxP-impacted systems across their lifecycle, including validation, periodic reviews, vendor qualification, audit readiness, change governance, and coordination with Quality and IT teams. The role serves as the primary IT subject matter expert during regulatory inspections and partner audits, establishes data integrity policies aligned with ALCOA+ principles, leads deviation investigations and CAPAs, and maintains IT SOPs and inspection-readiness documentation. It also partners with Quality to integrate IT compliance records with the broader eQMS, oversees training and competency records for IT and MSP personnel working on GxP systems, and supports timely deployment of laboratory, manufacturing, and clinical tools.
Requirements
- Bachelor's degree in Computer Science, Life Sciences, Quality, or a related field, or equivalent experience.
- At least 7 years of experience in IT/computer systems compliance within a GxP-regulated environment such as biotechnology, pharmaceuticals, or medical devices.
- 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 subject matter expert.
- Working knowledge of 21 CFR Part 11, Annex 11, ALCOA+, and data integrity principles.
- Experience with deviation/CAPA processes and root-cause analysis methodologies such as 5 Whys or 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 such as Veeva, MasterControl, or Qualio.
- Excellent communication skills, including the ability to explain technical and compliance risks to auditors and non-technical stakeholders.
- Ability to provide solutions and lead team members cross-functionally.
- Experience with Microsoft technologies such as O365 and MS Active Directory, and cloud-based storage platforms such as Egnyte, SharePoint Online, or Box.
- Familiarity with network, server, and end-user architecture compliance, including Windows and Mac, in support of laboratory, R&D, and scientific teams.
Nice To Haves
- Experience in a clinical-stage biotechnology or pharmaceutical environment; cell and gene therapy experience is 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 such as SIEM, EDR, and IAM within a GxP computerized systems framework.
Responsibilities
- Author, review, and execute validation lifecycle documentation—including Validation Plans, URS, IQ/OQ/PQ, and Validation Summary Reports—for GxP-impacted systems.
- Conduct routine periodic compliance reviews of active validated systems to ensure they remain in a validated state.
- Audit and qualify SaaS vendors and the MSP to assess whether their software development lifecycles meet regulatory standards.
- Serve as the primary IT subject matter expert during FDA, EMA, and partner audits, defending the compliance status of IT infrastructure.
- Establish and enforce data integrity policies aligned with ALCOA+ standards.
- Lead investigations into IT compliance deviations, author technical root-cause analyses, and implement CAPAs.
- Provide final compliance sign-off for IT changes through the Change Control Board, assessing impacts to validated baselines.
- Draft, revise, and maintain IT-specific Standard Operating Procedures.
- Provide dedicated validation capacity to facilitate deployment of laboratory, manufacturing, and clinical tools without regulatory delays.
- Partner with Quality to integrate IT validation packages, deviations, and CAPAs with the broader eQMS and inspection-readiness posture.
- Ensure IT and MSP staff working on GxP systems maintain current training records and demonstrate competency on relevant SOPs.
- Maintain inspection-readiness records, including the validated system inventory, open CAPAs, and periodic review status.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
