Site Inspection Lead, Quality Compliance – Global Standards

NCBioImpact; Holly Springs (NC); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech in Holly Springs seeks a Principal Quality Compliance Specialist to lead the site inspection program and own readiness for Health Authority inspections. You will embed a robust quality culture, coordinate regulatory engagement, and drive continuous improvement across manufacturing operations with a focus on aseptic drug product manufacturing.

The role requires 8–10 years in a GxP environment, proven coaching of SMEs for regulatory interactions, and exceptional cross-functional

Qualifications

• 8–10 years in a GxP environment
• Experience coaching SMEs for regulatory interactions
• Proven ability to lead site/global inspection readiness programs
• Expertise in global GxP regulations (FDA, EMA, ICH, ISO) and their application

Responsibilities

• Own Health Authority commitments, inspection responses, and post-inspection action tracking
• Maintain alignment with global quality and regulatory partners to facilitate health authority engagements
• Provide support to core quality systems to ensure compliance and continuous improvement

Skills

GxP compliance

Regulatory interactions

Cross-functional leadership

Audit readiness

Process improvement

Digital manufacturing

Education

Bachelor's degree in a scientific/technical discipline

Advanced degree preferred

Job description

Genentech in Holly Springs seeks a Principal Quality Compliance Specialist to lead the site inspection program and own readiness for Health Authority inspections. You will embed a robust quality culture, coordinate regulatory engagement, and drive continuous improvement across manufacturing operations with a focus on aseptic drug product manufacturing.

The role requires 8–10 years in a GxP environment, proven coaching of SMEs for regulatory interactions, and exceptional cross-functional