Temporary Compliance QA Manager - Systems

We are seeking an experienced
Temporary Compliance QA Manager
-Systems onsite in Alameda, CAto support quality systems, computerized system validation (CSV), and data integrity initiatives within a regulated environment. This role will be responsible for ensuring business systems remain compliant, efficient, and aligned with quality and regulatory requirements while supporting continuous improvement efforts across quality operations.

The ideal candidate will bring strong experience in system administration, computerized system validation, quality systems, and cross-functional collaboration. This position will serve as a key partner to business stakeholders, system owners, and quality teams to support compliant system implementation, maintenance, and optimization.

We are seeking an experienced
Temporary Compliance QA Manager
-Systems onsite in Alameda, CAto support quality systems, computerized system validation (CSV), and data integrity initiatives within a regulated environment. This role will be responsible for ensuring business systems remain compliant, efficient, and aligned with quality and regulatory requirements while supporting continuous improvement efforts across quality operations.

The ideal candidate will bring strong experience in system administration, computerized system validation, quality systems, and cross-functional collaboration. This position will serve as a key partner to business stakeholders, system owners, and quality teams to support compliant system implementation, maintenance, and optimization.

• Support the administration and maintenance of validated business systems and quality processes.
• Ensure compliance with applicable GxP, data integrity, quality, and regulatory requirements.
• Support quality management system activities, including change controls, deviations, CAPAs, and related quality records.
• Review and approve validation documentation and quality records as required.
• Author, review, and maintain policies, procedures, work instructions, and lifecycle documentation.
• Assist with internal and external audits, inspections, and audit readiness activities.

• Support computerized system validation activities throughout the system lifecycle.
• Participate in requirements gathering, risk assessments, testing, implementation planning, and validation execution.
• Perform or coordinate User Acceptance Testing (UAT), Performance Qualification (PQ), and related validation activities.
• Evaluate system enhancements, process changes, and configuration updates to ensure continued compliance.
• Maintain systems in a validated state and support ongoing data integrity initiatives.
• Identify risks and develop mitigation strategies to address compliance and operational concerns.

• Manage system access, user permissions, and user support activities.
• Create, maintain, and distribute system reports and metrics.
• Monitor system performance and proactively identify opportunities for improvement.
• Support configuration management and business process optimization initiatives.
• Collaborate with stakeholders to improve workflows, increase efficiency, reduce process gaps, and promote automation where appropriate.
• Maintain end-user support documentation, training materials, and reference guides.

• Partner with business owners, system owners, quality teams, and other stakeholders to support system and process improvements.
• Facilitate communication regarding system enhancements, compliance requirements, risks, and project timelines.
• Support implementation projects and drive timely resolution of issues and action items.
• Escalate risks, compliance concerns, and project challenges as appropriate.
• Generate and communicate metrics that support departmental and organizational objectives.

• Bachelor's degree in a scientific, technical, or related discipline with 7+ years of relevant experience, or an equivalent combination of education and experience.
• Minimum 5 years of experience supporting validated systems in a regulated environment.
• Experience with computerized system validation (CSV) and data integrity programs.
• Experience supporting quality systems, change control, deviation management, CAPA processes, and compliance activities.
• Experience working cross-functionally with business, technical, and quality stakeholders.
• Experience supporting audits, inspections, and regulatory compliance initiatives.

• Bachelor's degree in Science, Information Systems, Quality, Engineering, or a related field preferred.
• Equivalent combination of education and relevant experience will be considered.

• Strong knowledge of GxP environments, quality systems, and regulatory compliance requirements.
• Experience maintaining validated computerized systems throughout their lifecycle.
• Strong understanding of data integrity principles and compliance expectations.
• Excellent…