Quality Assurance Specialist - Document Control, CVRM

Genentech; Holly Springs (MS); On-site; USD 85,000 - 110,000; Full time

Job summary

Genentech in Holly Springs, NC is hiring a Document Control Specialist to manage Veeva Quality Documents and ensure regulatory compliance across site operations.

You will lead document lifecycle processes, coordinate with Engineering, MS&T, QC, QA, and Regulatory Affairs, and drive continuous improvement in documentation practices and archival standards.

Qualifications

• Bachelor's degree in a scientific/technical discipline required.
• 5–8 years in a GxP environment, with at least 3 years of accumulated experience.
• Experience in document control, archival systems, and regulatory compliance.

Responsibilities

• Serve as SME in Veeva Quality Documents; maintain workflows, templates, and hierarchies to ensure compliant document processes across business units.
• Collaborate with Engineering, MS&T, QC, Quality Assurance, and Operations to design Veeva workflows meeting their needs while maintaining compliance.
• Lead training initiatives on Veeva Quality Documents practices to maximize system use and adherence to procedures.
• Own the site archival room and retention program; implement standardized indexing, storage, and retrieval procedures; ensure regulatory compliance.
• Coordinate cross-functional records retention needs and support inspections, audits, and health authority engagement with proactive risk management.

Skills

Veeva Quality Docs

Document management

Regulatory compliance

Records management

Training leadership

Cross-functional collaboration

Education

Bachelor's degree in a scientific/technical discipline

Tools

GxP documentation systems

Job description

Welcome to Holly Springs, North Carolina- home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today's demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.

Join us in Holly Springs, where you won't just build a plant-you will build the future of medicine.

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.

This position is a unique opportunity to embed best practices in document stewardship into the site's operational design, support continuous improvement in information management, and drive operational excellence in document control and archival systems while serving as the central hub for enterprise wide documentation standards and practice.

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