Experience with Validation Lifecycle Management Systems (VLMS) like Veeva.
Familiarity with the Veeva Vault for document approval and record management.
Experience executing IOQ binder documentation in a GMP environment.
Proven ability to facilitate cross-functional working sessions with stakeholders.
Responsibilities
Lead cross-functional sessions to define ~350 validation entities.
Complete GVLMS worksheets using Veeva Validation Management module.
Pre-populate templates with source data to streamline meetings.
Ensure GVLMS compliance with 21 CFR Part 11.
Execute scanning and upload of IOQ binders into Veeva.
Follow SOPs for Document Control Room access and handling.
Maintain a Master Validation Data Repository for traceability across systems.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to work with cutting-edge technologies like Veeva.
Engagement with various phases of product validation.
Chance to influence the structure of validation processes.
Potential for involvement in innovative gene and cell therapy projects.
Full Job Description
Digital Validation / QMS Specialist
What you will do:
Facilitate and lead structured working sessions with cross-functional stakeholders (Validation, QC, Manufacturing, MSAT, Engineering) to define ~350 entities across Phase 1 and Phase 2.
Complete and route GVLMS worksheets within the Veeva Validation Management module, operating with Validation Lead role access within the Veeva Vault environment.
Pre-populate entity definition templates with available source data prior to each working session to maximize efficiency and minimize stakeholder time.
Ensure all GVLMS worksheets are completed, routed, and progressed through the approval workflow in compliance with 21 CFR Part 11 electronic record requirements.
Execute the scanning and Veeva upload of approximately 150 executed IOQ binders (estimated 50-200 pages each).
Follow the Document Control Room retrieval SOP for all binder access and chain-of-custody handling.
Build and maintain the Master Validation Data Repository - a traceability index covering 2-5 validation documents per system across ~350 qualified systems - drawing from documents already available in Veeva and the RMC Doc Control Room.
Verify upload accuracy against source binder index and escalate discrepancies within 1 business day.
Qualifications:
3-5+ years of validation experience in a regulated pharmaceutical, biotech, or CDMO environment.
Direct hands-on experience authoring and revising GxP validation documents - VMPs, SOPs, Guidance Documents, and validation templates.
Experience with Validation Lifecycle Management Systems (VLMS) - Veeva Validation Management, Kneat, ValGenesis, or equivalent platform.
Familiarity with the Veeva Vault ecosystem, including document routing, approval workflows, and 21 CFR Part 11 electronic record management.
Experience executing IOQ binder documentation, scanning, and electronic document management in a GMP environment.
Demonstrated ability to facilitate cross-functional working sessions with quality, engineering, and manufacturing stakeholders.
Preferred Qualifications
Experience in a cell therapy, gene therapy, or advanced biologics GMP manufacturing environment.
Prior experience supporting a GVLMS implementation or digital validation platform rollout.
Direct experience with Veeva Validation Management - entity definition, worksheet creation, routing, and approval workflows.
Familiarity with SAP PM (Plant Maintenance) for calibration or requalification scheduling.
Experience supporting multiple concurrent document types under a single change control record.
Prior experience working on a Pinnaql or similar consulting/managed service engagement - you understand the accountability model.
Bachelor's degree in Life Sciences, Engineering, Chemistry, or a related field.
