GxP Document Control Specialist — Veeva Expert

Genentech; Holly Springs (NC); On-site; USD 78,000 - 144,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits

Job summary

Genentech in Holly Springs, NC seeks a highly experienced Document Control Specialist to lead Veeva Quality Documents and manage comprehensive document lifecycles across Engineering, MS&T, QA, QC, and Operations. You will drive archival integrity, training, and standardized filing structures to ensure inspections readiness and compliance.

The role emphasizes collaboration with cross-functional teams, adherence to global GxP standards, and continuous improvement of information management

Qualifications

• Bachelor's degree in a scientific/technical discipline.
• Minimum of 5–8 years in a GxP environment, with at least 3 years in document control, records management, or quality documentation at a manufacturing site.
• 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.
• Experience translating regulatory documentation requirements into SOPs and control processes.
• Proven ability to develop, implement, or audit site-wide document control compliance programs.
• Strong organizational skills, meticulous attention to detail, and excellent time management with multiple priorities.
• Exceptional cross-functional communication and collaboration; ability to work with Quality, QC, Operations, Engineering, MS&T, Regulatory Affairs, and global teams.
• Proactive problem-solving to identify documentation gaps and drive timely resolutions.

Responsibilities

• Veeva Quality Documents management: develop workflows, templates, and hierarchies; support cross‑functional teams and ensure compliance.
• Cross‑functional document lifecycle management: align with Engineering, MS&T, QC, QA, and Operations to follow control procedures and global GxP standards.
• Records management and stakeholder engagement: own the archival room, implement standardized indexing, storage, retrieval, and retention.
• Coordinate regulatory documentation practices, inspections readiness, and continuous improvement of document control systems.

Skills

Cross-functional collaboration

Attention to detail

Problem-solving

Time management

Education

Bachelor's degree in a scientific/technical discipline

Tools

Veeva Quality Documents

Job description

Genentech in Holly Springs, NC seeks a highly experienced Document Control Specialist to lead Veeva Quality Documents and manage comprehensive document lifecycles across Engineering, MS&T, QA, QC, and Operations. You will drive archival integrity, training, and standardized filing structures to ensure inspections readiness and compliance.

The role emphasizes collaboration with cross-functional teams, adherence to global GxP standards, and continuous improvement of information management