Quality Assurance Specialist - Document Control, CVRM

Roche • Holly Springs, NC

2d • $77,500 - $143,900 • Onsite

About The Position

The Quality Assurance Specialist – Document Control, CVRM supports document management, regulatory compliance, and information stewardship at Roche/Genentech’s Holly Springs, North Carolina facility. This role manages document lifecycles and archival operations, helping ensure the integrity, accessibility, and compliance of quality and operational documents. It partners with Engineering, MS&T, Quality Assurance, Quality Control, Operations, Regulatory Affairs, and other teams to maintain document control practices, implement standardized procedures, and promote document excellence across the site.

The specialist serves as a subject matter expert for Veeva Quality Documents, maintaining and troubleshooting workflows, templates, document hierarchies, and related processes. The role also leads training on Veeva best practices and develops tailored workflows in collaboration with functional partners.

The position oversees cross-functional document lifecycle management and the site archival room and retention program. Responsibilities include maintaining filing and retrieval systems and metadata standards; monitoring document metrics; coordinating records transitions to archival status; auditing archival organization and accessibility; and managing document destruction in accordance with retention schedules and policies. The specialist also supports inspections, management reviews, and health authority engagement, and communicates documentation risks and compliance gaps to leaders.

The facility is a planned high-volume drug product manufacturing site focused on CVRM medicines, with a planned launch in 2028. Relocation assistance is not available. The expected salary range is $77,500–$143,900, with a discretionary annual bonus potentially available based on individual and company performance. The role qualifies for company benefits described through a linked benefits page.

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• 5–8 years of experience in a GxP environment, including at least 3 accumulated years in document control, records management, or quality documentation at a manufacturing site.
• Expertise in Veeva Quality Documents system administration and user support, including workflow configuration and data management.
• Hands-on experience organizing and managing physical or hybrid archival rooms, including records retention scheduling and legacy document management.
• Knowledge of global GxP regulations, including FDA, EMA, ICH, and ISO requirements, and their application to pharmaceutical manufacturing document control.
• Experience translating regulatory documentation requirements into practical SOPs and control processes.
• Demonstrated success developing, implementing, or auditing site-wide document control compliance programs.
• Strong organizational skills, meticulous attention to detail, and time management skills, including the ability to manage multiple priorities in a fast-paced environment.
• Excellent cross-functional communication and collaboration skills and ability to build relationships with Quality, QC, Operations, Engineering, MS&T, Regulatory Affairs, and global teams.
• Proactive problem-solving skills, including anticipating documentation gaps, escalating issues with context, and fostering transparent, solution-oriented dialogue.
• Ability to work in a dynamic environment while maintaining high quality and compliance standards.

Responsibilities

• Serve as a subject matter expert in Veeva Quality Documents.
• Maintain and troubleshoot Veeva Quality Document workflows, templates, and document hierarchies for document creation, review, approval, and distribution.
• Work with Engineering, MS&T, QC, and Operations to design Veeva workflows suited to their documentation needs while maintaining compliance.
• Lead training initiatives on Veeva Quality Documents best practices.
• Partner with cross-functional groups to ensure quality, regulatory, and operational documents follow control procedures and global GxP standards.
• Establish and maintain standardized document filing structures, retrieval systems, and metadata standards.
• Monitor document metrics, including approval timeliness, periodic reviews, and archival accuracy.
• Own the site archival room and document retention program, including procedures for indexing, storage, retrieval, and records classification.
• Coordinate transitions of records from active management to archival status.
• Conduct periodic audits of archival organization and accessibility.
• Manage document destruction in accordance with retention schedules and organizational policies.
• Work with functional partners to understand records retention needs and promote a proactive document control culture.
• Provide oversight of document control systems to support consistent compliance and continuous improvement.
• Support inspections, management reviews, and health authority engagement.
• Communicate documentation risks and compliance gaps to cross-functional leaders and escalate issues for resolution.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• The position qualifies for company benefits detailed at a provided link.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level