Senior Manufacturing Compliance Lead for Startup Plant

Genentech; Holly Springs (NC); On-site; USD 79,000 - 169,000; Full time

Job summary

Genentech in Holly Springs, NC, seeks a Senior/Principal Manufacturing Compliance Specialist to drive cGMP documentation and regulatory readiness for the Apollo 11 project. You will manage deviations, changes, and inspections while partnering across site operations, quality, regulatory affairs, and digital systems.

The role requires hands-on experience with MES/QMS (e.g., Veeva), strong RCA skills, and a bias for continuous improvement in a fast-paced, plant-of-the-future environment with up to

Qualifications

• Bachelor’s degree in life sciences, physical sciences, or engineering required.
• 2+ years hands-on experience owning deviations using RCA methods (5 Whys, Is/Is-Not).
• Experience authoring, reviewing, and approving cGMP docs in MES/QMS like Veeva.

Responsibilities

• Author, review, and approve cGMP documentation (SOPs, work instructions, training materials, eBRs) in MES.
• Identify and mitigate startup risks to ensure operational readiness.
• Manage deviations and change controls; support regulatory inspections as SME.
• Mentor P&C team and lead cross-functional issue resolution.
• Post go-live: drive continuous improvements and maintain KPIs.

Skills

Problem solving

Project management

Interpersonal skills

Technical writing

Education

Bachelor’s degree in life sciences/physical sciences/engineering

Tools

Veeva

MES

QMS

Job description

Genentech in Holly Springs, NC, seeks a Senior/Principal Manufacturing Compliance Specialist to drive cGMP documentation and regulatory readiness for the Apollo 11 project. You will manage deviations, changes, and inspections while partnering across site operations, quality, regulatory affairs, and digital systems.

The role requires hands-on experience with MES/QMS (e.g., Veeva), strong RCA skills, and a bias for continuous improvement in a fast-paced, plant-of-the-future environment with up to