Temporary Compliance QA Manager - Systems

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

Responsibilities

• 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.

Requirements

• 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.

Qualifications

• 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 process improvement and problem-solving skills.
• Ability to manage multiple priorities and drive projects to completion.
• Strong analytical, organizational, and decision-making capabilities.
• Excellent written, verbal, and presentation communication skills.
• Ability to translate technical information into user-friendly documentation and guidance.
• Collaborative approach with demonstrated success working across cross-functional teams.
• Results-oriented mindset with a commitment to quality and continuous improvement.

Education

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

Benefits

• Health coverage
• Life insurance
• Disability insurance
• 401k benefits