What are the responsibilities and job description for the GxP IT Systems & Cloud Operations Lead - Foster City, California position at Cube Hub, Inc.?
Job Title: GxP IT Systems & Cloud Operations Lead
Hybrid Position - Foster City - Local Candidates
Job Duration: 6 months
Hybrid Position - Foster City - Local Candidates
Job Duration: 6 months
This role is responsible for system administration, validation, and operational support within a life sciences environment to ensure compliant, reliable, and efficient systems.
Responsibilities include leading validation activities (authoring, execution, and review of protocols), project management and administering both GxP and business applications.
Responsibilities include leading validation activities (authoring, execution, and review of protocols), project management and administering both GxP and business applications.
Key Responsibilities
Provide operational and maintenance support for GxP and business applications, including incident resolution, access management, and job monitoring to ensure system reliability
Lead and execute validation activities (CSV lifecycle), including protocol authoring, review, execution, and audit readiness using ValGenesis
Manage quality events (Change Control, Deviations, CAPA) in Quality Management System to ensure compliance with GxP and regulatory requirements
Perform periodic maintenance activities for GxP and business systems, including SATR, server maintenance, backup/restore testing, and disaster recovery (DR) validation
Manage infrastructure lifecycle, including server upgrades, decommissioning, and cloud (AWS) resource optimization
Drive security and vulnerability management, ensuring timely patching and remediation across systems
Support system migrations and enhancements, including data mapping, validation, and on-prem to cloud transitions
Lead Agile/Scrum activities, including facilitating daily stand-ups, managing sprint tasks, and tracking team deliverables using tools such as JIRA/Azure DevOps
Participate in SQA testing and continuous improvement initiatives to enhance system performance and efficiency
Maintain dashboards and reports to monitor system performance and provide actionable insights
Conduct GxP system instructor-led training and engage stakeholders to ensure effective system usage, compliance, and adoption
Coordinate with cross-functional teams to prioritize work, manage dependencies, and drive operational excellence
Provide operational and maintenance support for GxP and business applications, including incident resolution, access management, and job monitoring to ensure system reliability
Lead and execute validation activities (CSV lifecycle), including protocol authoring, review, execution, and audit readiness using ValGenesis
Manage quality events (Change Control, Deviations, CAPA) in Quality Management System to ensure compliance with GxP and regulatory requirements
Perform periodic maintenance activities for GxP and business systems, including SATR, server maintenance, backup/restore testing, and disaster recovery (DR) validation
Manage infrastructure lifecycle, including server upgrades, decommissioning, and cloud (AWS) resource optimization
Drive security and vulnerability management, ensuring timely patching and remediation across systems
Support system migrations and enhancements, including data mapping, validation, and on-prem to cloud transitions
Lead Agile/Scrum activities, including facilitating daily stand-ups, managing sprint tasks, and tracking team deliverables using tools such as JIRA/Azure DevOps
Participate in SQA testing and continuous improvement initiatives to enhance system performance and efficiency
Maintain dashboards and reports to monitor system performance and provide actionable insights
Conduct GxP system instructor-led training and engage stakeholders to ensure effective system usage, compliance, and adoption
Coordinate with cross-functional teams to prioritize work, manage dependencies, and drive operational excellence
Qualifications & Experience
Bachelor's degree in Computer Science, Information Technology, or related discipline
Bachelor's degree in Computer Science, Information Technology, or related discipline
8 years of relevant experience
Demonstrated experience in GxP system administration and Computer System Validation (CSV)
Expertise in Server and infrastructure management, including backup/restore and disaster recovery
Expertise in Cloud platforms (AWS/Azure) and enterprise IT environments
Hands-on experience with validation and quality systems (ValGenesis or equivalent, Veeva QMS)
Proficiency with project and reporting tools, including Azure DevOps, JIRA, MS Visio
Demonstrated experience in GxP system administration and Computer System Validation (CSV)
Expertise in Server and infrastructure management, including backup/restore and disaster recovery
Expertise in Cloud platforms (AWS/Azure) and enterprise IT environments
Hands-on experience with validation and quality systems (ValGenesis or equivalent, Veeva QMS)
Proficiency with project and reporting tools, including Azure DevOps, JIRA, MS Visio
Nice to Have
Exposure to SAP ecosystems
Experience with automation and process optimization (RPA)
Exposure to SAP ecosystems
Experience with automation and process optimization (RPA)