Senior Quality Compliance Lead: QRM & Data Integrity

Roche; South San Francisco (CA); On-site; USD 94,000 - 175,000; Full time

Benefits offered by this job

Relocation assistance

Discretionary annual bonus

Job summary

Roche Genentech in Holly Springs, NC, seeks a Senior Quality Compliance Specialist to lead QRM, data integrity, and regulatory compliance initiatives within a fast-paced, high-tech manufacturing environment.

You will collaborate with Engineering, MSAT, Operations, Quality, and Global teams to embed a risk-based culture and ensure products meet global standards, including inspections and audits.

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 global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape.

Responsibilities

• Lead Quality Risk Management and Data Integrity initiatives.
• Serve as site SME for change control and chair the Change Review Board.
• Drive consistent execution of the change control program.
• Provide oversight of core quality systems to ensure compliance and continuous improvement.
• Support regulatory inspections and Health Authority engagement.

Skills

Quality Risk Management

Data Integrity

Change Control

Regulatory Compliance

Cross-functional Collaboration

GxP Knowledge

Education

Bachelor’s degree in science/technical discipline

Advanced degree preferred

Tools

Quality systems

Job description

Roche Genentech in Holly Springs, NC, seeks a Senior Quality Compliance Specialist to lead QRM, data integrity, and regulatory compliance initiatives within a fast-paced, high-tech manufacturing environment.

You will collaborate with Engineering, MSAT, Operations, Quality, and Global teams to embed a risk-based culture and ensure products meet global standards, including inspections and audits.