Senior Quality Compliance Leader — QRM & Data Integrity

Genentech; Holly Springs (NC); Vor Ort; USD 94.000 - 175.000; Vollzeit

Benefits dieser Stelle

Relocation assistance

Zusammenfassung

Genentech in Holly Springs, NC seeks a Senior Quality Compliance Specialist to integrate risk-based quality practices into aseptic drug product manufacturing startups. You will design and own Quality Risk Management and Data Integrity initiatives across cross-functional teams to deliver compliant, high-quality products in a fast-paced, technically advanced environment.

Relocation support is available; the role demands 8–10 years in GxP, with 4+ years leading QRM, Data Integrity or Change Control

Qualifikationen

• 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 site.
• Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and digital manufacturing.
• Experience with regulatory inspections and health authority interactions.

Aufgaben

• Lead QRM activities and maintain the site risk register.
• Own Data Integrity program for automated and digital systems.
• Chair Change Review Board and oversee high-impact modifications.
• Provide cross-functional quality leadership and issue escalation.
• Support inspections, recalls, and health authority engagements.

Kenntnisse

Quality Risk Management

Data Integrity

Change Control

Regulatory compliance

Cross-functional collaboration

Risk-based decision-making

GxP knowledge

Ausbildung

Bachelor's degree in scientific/technical discipline

Advanced degree preferred

Tools

FMEA

PHA

Jobbeschreibung

Genentech in Holly Springs, NC seeks a Senior Quality Compliance Specialist to integrate risk-based quality practices into aseptic drug product manufacturing startups. You will design and own Quality Risk Management and Data Integrity initiatives across cross-functional teams to deliver compliant, high-quality products in a fast-paced, technically advanced environment.

Relocation support is available; the role demands 8–10 years in GxP, with 4+ years leading QRM, Data Integrity or Change Control