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

Apply Now