Senior Quality Compliance Leader – Data Integrity & QRM

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 94,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs, NC is seeking a Senior Quality Compliance Specialist to embed a risk-based quality culture and data integrity into aseptic drug product manufacturing. You will lead QRM, data integrity, and change control programs across cross-functional teams.

This role collaborates with Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global organizations to ensure compliance with FDA/EMA/ICH/ISO standards, manage inspections, and drive continuous improvement at a site

Qualifications

• Minimum 8–10 years in a GxP environment with at least 4 years leading QRM, Data Integrity or Change Control at a manufacturing site.
• Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and practical application in a digital sterile manufacturing landscape.
• Experience developing, auditing, or implementing site-wide Data Integrity compliance programs within highly automated/digital facilities.

Responsibilities

• Oversee Quality Risk Management, Data Integrity, and Change Control programs.
• Lead site Change Review Board and cross-functional approval of high-impact changes.
• Provide oversight of core quality systems to ensure compliance and continuous improvement.
• Engage with Health Authority inspections and regulatory interactions.

Skills

Quality risk management

Data integrity

Change control

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree in science/engineering

Job description

Genentech in Holly Springs, NC is seeking a Senior Quality Compliance Specialist to embed a risk-based quality culture and data integrity into aseptic drug product manufacturing. You will lead QRM, data integrity, and change control programs across cross-functional teams.

This role collaborates with Engineering, MSAT, Warehouse, Operations, Quality, QC, and Global organizations to ensure compliance with FDA/EMA/ICH/ISO standards, manage inspections, and drive continuous improvement at a site