Senior Manufacturing Compliance Leader

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, deviations, and change controls during facility startup and go‑live. You will partner with Quality, Regulatory, and Digital Systems to ensure compliance and readiness.

You will own documentation updates, mentor the P&C team, and support regulatory inspections as SME. On-site work with travel ±10% is expected, with a competitive bonus potential.

Qualifications

• Bachelor’s degree in life sciences, physical sciences, engineering and 2–4 (Senior) or 5–7 (Principal) pharma experience.
• Hands-on deviations ownership using RCA methodologies (5 Whys, Is/Is-Not).
• Experience authoring, reviewing and approving cGMP documentation in MES/QMS systems.

Responsibilities

• Author, review, and approve cGMP docs (SOPs, work instructions, training, eBRs) in MES.
• Identify and mitigate startup process risks for operational readiness.
• Own major and minor deviations, including third party.
• Own change controls.
• Develop learning materials for the CFI team.
• Support initial regulatory inspections as SME.
• Manage deviations using RCA tools (5 Whys, Is/Is-Not).
• Lead change controls and track KPIs.
• Update documentation and tracking tools for improvements.
• Present as SME during inspections and site tours.
• Mentor P&C team and drive cross-functional issue resolution.

Skills

Problem solving

Project management

Interpersonal skills

Presentation

Coaching others

Deviations RCA

Technical writing

Education

Bachelor's degree in life sciences, physical sciences, or engineering

Tools

MES

QMS/QDocs (Veeva)

Job description

Genentech in Holly Springs, NC, seeks a Senior/Principal Manufacturing Compliance Specialist to drive cGMP documentation, deviations, and change controls during facility startup and go‑live. You will partner with Quality, Regulatory, and Digital Systems to ensure compliance and readiness.

You will own documentation updates, mentor the P&C team, and support regulatory inspections as SME. On-site work with travel ±10% is expected, with a competitive bonus potential.