Temporary Compliance QA Manager - Systems

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

We are seeking a QA Manager to support Quality Systems, Computer System Validation (CSV), Data Integrity (DI), and system administration activities within a regulated environment. This role will ensure validated systems remain compliant, support quality processes, and drive continuous improvement initiatives.

Position Overview

We are seeking a QA Manager to support Quality Systems, Computer System Validation (CSV), Data Integrity (DI), and system administration activities within a regulated environment. This role will ensure validated systems remain compliant, support quality processes, and drive continuous improvement initiatives.

Key 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.

Required Qualifications

• Bachelor's degree in a scientific, technical, or related discipline; equivalent experience may be considered.
• 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.
• Strong analytical, organizational, and communication skills.

Preferred Qualifications

• Experience with Quality Management Systems, document management systems, learning management systems, or other regulated applications.
• Experience supporting SaaS-based systems and enterprise quality platforms.
• Experience supporting regulatory audits, inspections, and compliance programs.
• Experience developing quality metrics, dashboards, and reporting tools.
  

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].