Senior Quality Risk & Data Integrity Lead

Genentech; North Carolina; On-site; USD 94,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Discretionary annual bonus

Job summary

Genentech in Holly Springs, NC, seeks a Senior Quality Compliance Specialist to drive QRM, data integrity, and change control within a highly automated, sterile drug product setting.

You will collaborate with Engineering, MSAT, Operations, and Global teams to embed risk-based controls and ensure compliance with FDA/EMA expectations, while supporting continuous improvement and a strong quality culture.

Qualifications

• Must hold a scientific/technical degree with 8–10 years in a GxP environment.
• At least 4 years leading QRM, Data Integrity or Change Control programs.
• Strong knowledge of global GxP regulations and inspections.

Responsibilities

• Lead Quality Risk Management (QRM) activities and maintain site risk registers.
• Own Data Integrity programs across automated, digital, and analytical systems.
• Chair Change Review Board and drive high-impact change control activities.
• Provide cross-functional quality support and sustain regulatory readiness.

Skills

GxP experience

QRM leadership

Data Integrity

Change Control

Regulatory inspections

Cross-functional collaboration

Education

Bachelor's degree in scientific/technical discipline

Advanced degree preferred

Job description

Genentech in Holly Springs, NC, seeks a Senior Quality Compliance Specialist to drive QRM, data integrity, and change control within a highly automated, sterile drug product setting.

You will collaborate with Engineering, MSAT, Operations, and Global teams to embed risk-based controls and ensure compliance with FDA/EMA expectations, while supporting continuous improvement and a strong quality culture.