Teams at GAP Solutions, Inc.

Provides independent quality oversight for GxP-regulated computerized systems throughout implementation, validation, maintenance, and retirement. Applies GxP, CSA, CSV, GAMP5, 21 CFR Part 11, and ICH E6 requirements; supports testing, incident management, SOP development, validation documentation, risk assessments, audits, vendor assessments, and stakeholder training. Collaborates with cross-functional teams to ensure systems meet regulatory and quality standards.

Administer enterprise SaaS and AWS cloud environments, including platform onboarding, identity and access management, SAML/OIDC integrations, troubleshooting, monitoring, documentation, and security compliance. Resolve web application issues, maintain reliable system operations, and collaborate with cross-functional teams. The role requires extensive systems administration experience and familiarity with AWS services, networking, vulnerability remediation, and regulated systems.

Conduct bioinformatics analysis of exome, targeted, bulk RNA-sequencing, single-cell RNA-sequencing, and other genomic data. Develop and optimize sequencing pipelines, annotation algorithms, databases, and visualization workflows; process data on NIH Biowulf clusters; maintain cBioPortal; interpret results; prepare reports, presentations, and manuscripts; document tools; and train staff on genomic analysis methods.