fda-21-cfr-part-11 jobs in San Diego

Provide IT infrastructure, application, and technical support for laboratory environments in life sciences/pharmaceutical/biotechnology settings. Install, configure, maintain, and troubleshoot laboratory IT systems including LIMS, ELN, LES, CDS applications, laboratory instruments, Windows servers, Active Directory, and networking.…See more Support GxP-regulated environments, system validation, change control, and audit activities while ensuring security, availability, and data integrity.

Director of IT seeking an experienced leader to oversee IT governance, compliance, and risk management for a biotech company. Responsibilities include drafting and maintaining IT policies aligned with regulations (GDPR, HIPAA, ISO 27001, FDA 21 CFR Part 11, SOX), leading internal and external audits, conducting risk assessments, developing IT quality management systems, and managing an IT team and budget.…See more The role requires 8+ years of IT experience with 3+ years in leadership, strong technical writing ability, and expertise in cloud platforms, network security, and data privacy.

A senior technical architect role responsible for designing cloud and security solutions for multi-client MSP environments, conducting technical quality assurance across engineering teams, and establishing configuration standards and documentation. The role requires 5+ years of hands-on infrastructure/cloud/security/identity experience with deep expertise in Azure, Entra ID, and the Microsoft Defender/Security suite, plus demonstrated ownership-level depth across endpoint protection, RMM, network/firewall, and VDI platforms.…See more The architect will mentor junior engineers, sanity-check technical feasibility and scope, and validate Statements of Work before client delivery while owning the technical planning for complex multi-workstream projects.

This Staff QA Engineer role leads the design, development, validation, and deployment of Quality Assurance metric dashboards for manufacturing operations, with expertise in medical device quality management systems (QMS), regulatory compliance (FDA 21 CFR Part 11, ISO 13485), and non-conforming event management. The position coordinates site and corporate management reviews, participates in internal and external audits, and supports cross-functional teams in CAPA, risk management, and validation activities.…See more The engineer applies statistical analysis and dashboard tools (Power BI, Tableau, SQL, BigQuery) to drive quality decisions and operational excellence. Success requires direct experience with QMS, nonconforming materials, auditing, medical device regulations, and the ability to lead diverse functional groups in a fast-paced environment.