Quality Systems Consultant

Duration: 6–12 months, with potential for extension We are seeking a Consultant, Quality Systems to support the Director of Quality within a pharmaceutical/biotechnology organization. This on-site consultant will play a key role in maintaining compliant quality documentation, supporting training administration, and assisting with audit-readiness activities in a fast-paced GxP-regulated environment. The ideal candidate will have hands-on experience with Veeva Vault QualityDocs and ComplianceWire, as well as a strong understanding of document control, training coordination, and quality systems execution in a regulated environment. Key Responsibilities Process controlled documents, including SOPs, work instructions, forms, and policies, through electronic workflow systems. Manage document metadata, routing, approvals, effective dates, and archival activities within Veeva Vault QualityDocs. Support periodic document review activities and maintain document control queues. Ensure compliance with internal document control procedures and GxP requirements. Assist with updates and revisions to Quality Management System documentation. Support change control activities and help drive the timely completion of document-related tasks. Identify opportunities for process improvements within Quality Systems operations. Assign and monitor GxP training activities within Compliance Wire. Track training completion and follow up with learners and functional teams. Troubleshoot user and learner issues related to training assignments and curricula. Assist with maintaining training curricula and course content. Escalate system integration, workflow, or configuration issues to system owners. Pull and organize document and training records for internal audits, client audits, and regulatory inspections. Maintain records in accordance with GxP and Good Documentation Practice (GDP) requirements. Support remediation and follow-up activities associated with audit observations. Assist with inspection readiness activities, including back-room support and document retrieval. Support CAPA, non-conformance, and quality records management activities as needed. Qualifications Bachelor’s degree in Life Sciences, Quality, Engineering, or related technical discipline. 6+ years of experience in Quality Assurance, Quality Systems, or Document Control within the pharmaceutical or biotechnology industry. Hands‑on experience with Veeva Vault QualityDocs required. Experience supporting ComplianceWire learning management systems preferred. Exposure to CAPA, change controls, audit support, and inspection readiness activitives. Experience working within fast‑paced, highly regulated environments. Experience supporting pharmaceutical or biotech manufacturing and quality operations. Understanding of Good Documentation Practices (GDP) and GxP requirements. Strong organizational skills with the ability to manage multiple priorities and deadlines. Proficiency with Microsoft Office applications and electronic document management systems. Strong communication and collaboration skills with the ability to work cross‑functionally in a regulated environment. #J-18808-Ljbffr Kaye/Bassman International