System Specialist

We are seeking a highly organized and detail-oriented System Specialist to support our pharmaceutical manufacturing operations through effective management of the Document Management System (DMS) in preparation to a migration to Veeva Vault system. This role is critical to ensuring documentation related to GMP manufacturing processes is current, compliant, and readily accessible. The System Specialist will support cleanup activities related to the DMS, manage the review and approval workflows of global documents, monitor and report periodic reviews, manage translation activities, and support end users across the organization., Document Lifecycle Management:

Manage the end-to-end document control process of global documents in DMS, ensuring timely creation, review, approval, issuance, and archival of controlled documents such as SOPs, work instructions, and validation protocols.

DMS Coordinator Role:

Act as Global Super User/Coordinator of DMS application covering:

• Management of ownership of documents
• Management of properties for effective documents
• Creation and maintenance of distribution lists
• Management of Secure groups
• Management of review and approval workflows across cross-functional teams including QA, Manufacturing, QC, Engineering, and Regulatory Affairs to ensure alignment and timely approvals.
• Maintenance of master data
• User permission management: review, update, grant/remove
• Act as the final approver (gatekeeper) for global documentation during approval workflows
• Support the preparation and distribution of bi-weekly reports on document creation and revisions
• Support all Cleanup activities of the current DMS in preparation for a new eDMS.

Periodic Review Monitoring:

Track, monitor and update the Past Overdue Periodic Review Reported, and create monthly reports of periodic document reviews in accordance with GMP and internal procedures. Escalate overdue tasks and non-compliance issues to department leads and Quality leadership.

Translation Coordination:

Oversee the translation of controlled documents to support global manufacturing sites. Ensure translated versions become effective simultaneously with the English master to maintain operational consistency.

User Support and Training:

Act as the primary point of contact for DMS end users (via QMS Mailbox/F11 tickets), providing system navigation support, troubleshooting, and training to ensure proper use and compliance with established document control procedures, and serve as Local Headquarter (Basel) Training Administrator for Cornerstone.

System Optimization and Compliance:

Collaborate with QA and IT teams to enhance document workflows and ensure the document management system is optimized for pharmaceutical manufacturing and compliant with regulatory authority requirements (e.g., FDA, EMA), while supporting the Global QMS-DMS team in implementing system improvements, managing technical issues, and contributing to OQ/PQ testing.

• Bachelor’s degree in Life Sciences, Quality, or a related technical field (or equivalent experience)
• 3+ years of experience in document control within a GMP pharmaceutical manufacturing environment
• Veeva Vault experience highly desired
• Proficiency with DMS (D2) or similar electronic document management systems
• Strong understanding of GMP regulations (21 CFR Part 11, EU Annex 11), and pharmaceutical documentation requirements
• Exceptional attention to detail, organizational, and time-management skills
• Strong interpersonal and communication skills with the ability to work across departments