Senior Compliance QA Lead – CSV & Data Integrity

Advanced Clinical; Alameda (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401k benefits

Job summary

Advanced Group is seeking a QA Manager to support Quality Systems, CSV, Data Integrity, and system administration activities within a regulated environment. This role will ensure validated systems remain compliant, support quality processes, and drive continuous improvement initiatives.

The position requires 7+ years in quality systems and CSV, with hands-on experience in validated GxP environments, deviation management, and change control.

Qualifications

• Bachelor's degree in a scientific, technical, or related discipline.
• 7+ years of experience in Quality Systems, CSV, Data Integrity, or regulated system administration.
• 5+ years supporting validated GxP systems in a regulated environment.
• Strong knowledge of CSV, Data Integrity, CAPA, change control, deviation management, and Quality Systems.
• Experience supporting validation testing, system implementations, and process improvement initiatives.

Responsibilities

• Support CSV, Data Integrity, and Quality Management System (QMS) activities.
• Administer validated systems, including user access, configuration, documentation, and compliance oversight.
• Gather requirements, support system enhancements, and execute validation activities, including UAT and qualification testing.
• Manage deviations, CAPAs, change controls, and related quality system processes.
• Review and approve validation documentation, quality records, and system lifecycle deliverables.
• Generate reports, metrics, and dashboards to support compliance and operational objectives.
• Maintain procedures, system documentation, and user support materials.
• Collaborate with cross-functional teams to resolve issues, manage risks, and support audits and inspections.

Skills

Quality Systems

CSV

Data Integrity

CAPA

Change Control

Deviation Management

Regulatory Compliance

Validation Testing

Analytical Skills

Communication Skills

Education

Bachelor's degree in a scientific/technical discipline

Job description

Advanced Group is seeking a QA Manager to support Quality Systems, CSV, Data Integrity, and system administration activities within a regulated environment. This role will ensure validated systems remain compliant, support quality processes, and drive continuous improvement initiatives.

The position requires 7+ years in quality systems and CSV, with hands-on experience in validated GxP environments, deviation management, and change control.