Senior Quality Compliance Lead – Digital QMS, CVRM

Genentech; Holly Springs (NC); Presencial; USD 115.000 - 213.000; Jornada completa

Descripción de la vacante

Genentech in Holly Springs, NC seeks a Principal Quality Compliance Specialist to lead strategic quality initiatives across the site and global network. You will act as the expert on digital regulatory requirements, embedding a robust QMS and risk-based culture to ensure compliant, high-quality drug product manufacturing.

This role drives continuous improvement and cross-functional collaboration. The position emphasizes a strong background in GxP, data integrity, and regulatory inspections, with

Formación

• Bachelor's degree in a scientific/technical discipline.
• 8–10 years in a GxP environment with 4+ years leading strategic quality improvement projects.
• Deep expertise in global GxP regulations (FDA, EMA, ICH, ISO).
• Experience with Annex 4 and Annex 11 compliance in highly automated environments.
• Proven ability to translate Data Integrity and QRM into robust operational controls.
• Experience with defining controls and governance for AI (Annex 22) preferred.
• Track record of leading cross-functional teams to drive improvements.
• Experience with regulatory inspections and health authority interactions.

Responsabilidades

• Lead Strategic Quality Projects across the site and global network.
• Act as the site liaison for global compliance trends and improvements.
• Translate network mandates into actionable project plans and local strategies.
• Drive site quality improvement initiatives and operational excellence.
• Coordinate deep-dive risk assessments and apply QRM methods.
• Provide SME support for digital regulatory requirements and inspections.
• Support core quality systems and key compliance processes.
• Mentor teams to foster proactive issue resolution and risk awareness.

Conocimientos

GxP expertise

Regulatory inspections

Data Integrity

QRM methods

Lean Six Sigma

Cross-functional leadership

Risk assessment

Digital compliance

Educación

Bachelor's in science

Descripción del empleo

Genentech in Holly Springs, NC seeks a Principal Quality Compliance Specialist to lead strategic quality initiatives across the site and global network. You will act as the expert on digital regulatory requirements, embedding a robust QMS and risk-based culture to ensure compliant, high-quality drug product manufacturing.

This role drives continuous improvement and cross-functional collaboration. The position emphasizes a strong background in GxP, data integrity, and regulatory inspections, with