New · posted Oct 25
Genentech · Biotechnology
Quality Assurance Specialist - Document Control, CVRM
- Holly Springs, NC
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
What you need
- 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.
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.
Pay
$77,500 – $143,900 a year
Employer providedIf 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.
Where you'll work
Holly Springs, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Holly Springs, NCEqual opportunity, accessibility and legal noticesGenentech's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 25, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in North Carolina13 roles publishing pay
Senior & Principal roles in the US319 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $77,500 | — | $143,900 |
| North Carolina (middle half) | $106,000 | $122,000 | $134,500 |
| All US (middle half) | $103,250 | $119,000 | $139,000 |
This role: Genentech's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 25, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 925 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Genentech's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs17
- GMP and compliance11
- Collaboration and leadership9
- Data and digital systems3
- Quality systems and risk2
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Genentech on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 4
- Locations
By discipline
- Quality13 65%
- Compliance & Safety5 25%
- Regulatory2 10%
By level
- Senior & Principal17 85%
- Director2 10%
- Manager1 5%
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Quality Assurance Specialist - Document Control, CVRM at Genentech
Open until filled. $78K–$144K a year, employer provided.