Quality Assurance Specialist - Document Control, CVRM

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 78,000 - 144,000; Full time

Job summary

Genentech in Holly Springs is seeking a highly detail-oriented Document Control Specialist to ensure the integrity and compliance of quality and operational documents. You will manage document lifecycles, work with Engineering, MS&T, QC, and Quality Assurance, and embed best practices across the site.

You will lead Veeva Quality Documents workflows, configuration, and training, and own the site archival program, including retention scheduling and audits.

Qualifications

• Bachelor's degree in a scientific/technical field required.
• 5–8 years in a GxP environment with document control experience.
• 3+ years in document control, records management, or quality documentation at a manufacturing site.
• Experience with SOPs and regulatory documentation requirements.

Responsibilities

• Lead Veeva Quality Documents workflows, templates, and hierarchies.
• Collaborate with Engineering, MS&T, QC, and Operations to tailor workflows.
• Lead training on Veeva Quality Documents best practices.
• Ensure compliance with global GxP standards across documentation.

Skills

Veeva Quality Documents

Regulatory compliance

GxP experience

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in a scientific/technical discipline

Tools

Veeva Quality Documents

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 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.

Relocation Assistance is not available for this role.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $77,500 - $143,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.