Quality Assurance Specialist - Document Control, CVRM

The Opportunity

We are looking for a highly detail-oriented Document Control Specialist with strong experience in document management, regulatory compliance, and information stewardship. This critical role is essential for ensuring the integrity, accessibility, and compliance of all quality and operational documents. As a key member of the Document Control team, you will hold a strategic responsibility for the comprehensive management of document lifecycles and archival operations. You will work in tandem with cross-functional partners, including Engineering, MS&T, Quality Assurance, Quality Control, etc, to maintain robust document control practices, implement standardized procedures, and establish a culture of document excellence throughout the site.

What You'll Do

Veeva Quality Documents Management

• Serve as a subject matter expert in Veeva Quality Documents.
• Maintain and troubleshoot Veeva Quality Document workflows, templates, and document hierarchies to ensure efficient document creation, review, approval, and distribution processes across all business units.
• Collaborate with Engineering, MS&T, QC, and Operations to understand unique documentation needs and design tailored Veeva workflows that support their processes while maintaining compliance.
• Lead training initiatives on Veeva Quality Documents best practices, ensuring cross-functional teams maximize system capabilities and maintain compliance with established procedures.

Cross-Functional Document Lifecycle Management

• Partner with Engineering, MS&T, QC, Quality Assurance, and Operations to ensure all quality, regulatory, and operational documents follow established control procedures and comply with global GxP standards.
• Establish and maintain standardized document filing structures, retrieval systems, and metadata standards in collaboration with cross-functional teams to facilitate rapid, accurate document location during inspections and audits.
• Monitor document metrics, including approval timeliness, periodic reviews, and archival accuracy across all functional areas.

Records Management and Stakeholder Engagement

• Own the site archival room and document retention program, designing and implementing standardized procedures for document indexing, storage organization, retrieval protocols, and records classification in compliance with global regulatory requirements.
• Coordinate the transition of records from active management to archival status, conduct periodic audits to verify proper organization and accessibility, and manage document destruction in compliance with retention schedules and organizational policies.
• Partner cross-functionally with Engineering, MS&T, QC, Quality Assurance, Operations, and Regulatory Affairs to understand records retention needs, drive a proactive document control culture, provide oversight of document control systems for consistent compliance and continuous improvement, and support compliance processes including inspections, management review, and health authority engagement.
• Proactively communicate documentation risks and compliance gaps to cross-functional leaders, escalating issues with appropriate context and urgency to drive timely resolution.

Who You Are

• Bachelor's degree in a scientific/technical discipline
• Minimum of 5–8 years in a GxP environment, with at least 3 years of accumulated experience in document control, records management, or quality documentation at a manufacturing site.
• Demonstrated expertise with Veeva Quality Documents system administration and user support, including workflow configuration and data management.
• Hands-on experience organizing and managing physical or hybrid document archival rooms, including records retention scheduling and legacy document management.
• Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application to document control in pharmaceutical manufacturing.
• Experienced with the translation of regulatory documentation requirements into practical standard operating procedures (SOPs) and control processes.
• Demonstrated success developing, implementing, or auditing site-wide document control compliance programs.
• Strong organizational skills, meticulous attention to detail, and excellent time management with the ability to manage multiple priorities in a fast-paced environment.
• Exceptional cross-functional communication and collaboration skills; able to work effectively and build strong relationships with Quality, QC, Operations, Engineering, MS&T, Regulatory Affairs, and global teams.
• Proactive problem-solver who anticipates documentation gaps, escalates issues with appropriate context, and fosters a culture of transparent, solution-oriented dialogue across the organization.
• Ability to work in a dynamic environment while ensuring the highest quality and compliance standards.