Certified QMS Administrator with CSV Experience

Title: Certified QMS Administrator (Part-Time)

Client: US – Based West Coast

Hours: ~10 hours per week

Timezone Requirement: Must be available during US Pacific Time (PST), approximately 9/10 AM – 12/1 PM PST

Overview

We are seeking a Certified QMS Administrator to support the administration and ongoing compliance of Quality Management Systems for US-based life sciences clients. This is a part-time role suited for experienced professionals with strong knowledge of GxP quality processes, QMS workflows, and Computer System Validation (CSV).

Key Responsibilities

• Provide Administration Support of Client’s QMS platform – ACE QMS (PSC Biotech)
• Configure and manage QMS workflows including Deviations, CAPA, Change Control, Document Management
• Support QMS Integration with ComplianceWire LMS
• Support system lifecycle compliance activities including:
• Release Impact Assessments
• Periodic Reviews
• User Access Reviews
• Change Controls
• Work closely with business stakeholders to resolve issues and/or make configuration changes
• Ensure system administration activities remain aligned with CSV and GxP compliance requirements
• Support ongoing system maintenance and documentation updates

Qualifications

• Certified or demonstrable experience as a QMS Administrator (ACE or Veeva or Trackwise) in regulated environments
• Hands-on experience administering ACE QMS, Veeva Vault QMS, TrackWise, or similar eQMS platforms
• Strong understanding of GxP quality processes and compliance requirements
• Experience supporting CSV-related activities for regulated systems
• Proven experience working with US-based clients and distributed teams
• Excellent English communication skills (written and verbal)

Preferred

• Experience supporting life sciences organizations (pharma, biotech, or medical devices)
• Familiarity with regulated SaaS platforms and validation practices

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