Document Controller Document Controller

Key Responsibilities:
• Owns and manages the end-to-end document control lifecycle for QA documentation, including creation, revision, review, approval, issuance, archiving, and retirement, in compliance with GQS and LQS requirements
• Provides subject matter expertise on document control standards, processes, and best practices to QA and cross-functional partners
• Reviews QA documentation for accuracy, completeness, formatting, and compliance with quality standards and regulatory expectations
• Leads and supports periodic review and gap assessment activities, identifying documentation gaps, risks, and remediation needs
• Coordinates and facilitates document routing through electronic or manual review and approval workflows, ensuring timely execution
• Maintains controlled document repositories to ensure documents are current, traceable, and readily accessible for operations and inspections
• Tracks, monitors, and reports documentation status, metrics, and deliverables to QA Operations leadership
• Supports inspection readiness activities by ensuring controlled documents are inspection-ready and aligned with site practices
• Partners with QA and operational stakeholders to support documentation strategies for new processes, changes, and remediation efforts
• Identifies opportunities to improve document control efficiency, consistency, and compliance


Quals--
The experienced Document Controller supports the GQC QA Operations team by managing the full lifecycle, control, and governance of quality documentation required for compliance with Global Quality Standards (GQS), *** Quality Standards (LQS), and applicable departmental procedures. This role ensures documentation is consistently controlled, inspection-ready, and aligned with regulatory expectations, while providing subject matter expertise and guidance on document control processes across QA and site functions.
Minimum Experience Requirements:
• Minimum of 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environment
• Demonstrated hands-on experience managing controlled documents using Veeva QualityDocs (required)
• Experience supporting inspections, audits, periodic reviews, and documentation gap assessments
Educational Requirements:
• Bachelor's degree or equivalent experience
• Strong written and verbal communication skills
• Detailed knowledge of Quality policies, procedures, and document control principles
• Strong attention to detail, organizational skills, and ability to manage multiple priorities
• Proven ability to work independently and influence across functions