Senior Quality Compliance Lead - Data Integrity & Risk

Genentech, Inc.; Holly Springs (NC); On-site; USD 94,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech, Inc. in Holly Springs, North Carolina is building a cutting-edge facility focused on aseptic drug product manufacturing.

We are seeking a Senior Quality Compliance Specialist to embed risk-based quality and data integrity into the operational design from day one. The role requires strong expertise in QRM, data integrity, and change control, with collaboration across Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global teams to ensure compliance with global regulations and

Qualifications

• Bachelor's degree in a scientific/technical discipline; advanced degree preferred.
• 8–10 years in a GxP environment with 4 years leading QRM, Data Integrity or Change Control at a manufacturing site.
• Deep knowledge of FDA, EMA, ICH, ISO and their application in digital sterile manufacturing.
• Experience translating QRM into operational controls for drug products.

Responsibilities

• Lead site Quality Risk Management activities and maintain the site risk register.
• Coordinate and drive QRM activities including FMEA/PHA.
• Own data integrity program and ensure compliance across systems.
• Chair Change Review Board and oversee high-impact modifications during commissioning and validation.
• Provide cross-functional leadership to resolve compliance issues and drive continuous improvement.

Skills

Quality Risk Management

Data Integrity

Change Control

Quality Compliance

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in a scientific/technical discipline

Advanced degree preferred

Job description

Genentech, Inc. in Holly Springs, North Carolina is building a cutting-edge facility focused on aseptic drug product manufacturing.

We are seeking a Senior Quality Compliance Specialist to embed risk-based quality and data integrity into the operational design from day one. The role requires strong expertise in QRM, data integrity, and change control, with collaboration across Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global teams to ensure compliance with global regulations and