Contractor, Quality Systems

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 Quality Docs and Compliance Wire, as well as a strong understanding of document control, training coordination, and quality systems execution in a regulated environment.

• 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 Quality Docs.
• 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.

• Bachelor’s degree in Life Sciences, Quality, Engineering, or related technical discipline.
• 2–4 years of experience in Quality Assurance, Quality Systems, or Document Control within the pharmaceutical or biotechnology industry
• Hands-on experience with Veeva Vault Quality Docs required
• Experience supporting Compliance Wire learning management systems preferred.
• Exposure to CAPA, change controls, audit support, and inspection readiness activities
• 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