Senior Manager, Assembly & Packaging Excellence

Genentech; Holly Springs (MS); Vor Ort; USD 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Health insurance

Zusammenfassung

Genentech in Holly Springs, NC seeks a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project. You will drive operational readiness, compliance, training, and continuous improvement at the startup site and transition to post go-live leadership in deviations, RCA, and change controls.

You will shape governance for MES batch records, lead regulatory inspection readiness, and develop a high-performing team focused on excellence and accountability.

Qualifikationen

• BS/MS in Science or Engineering with 12+ years in bio/pharma manufacturing, quality, or engineering.
• Practical knowledge of device assembly and packaging equipment.
• Experience leading cross-functional teams in manufacturing operations.

Aufgaben

• Oversee SOP lifecycle, risk management, MES batch records, and regulatory readiness for Assembly & Packaging.
• Lead governance for deviations, change controls, RCA, and investigations with third parties.
• Direct learning and capability development for the A&P team and regulatory inspections readiness.
• Drive change management, approval, and execution of change controls across functions.

Kenntnisse

Packaging knowledge

Quality systems

Root Cause

Change control

Ausbildung

BS/MS in Science or Engineering

Jobbeschreibung

Genentech in Holly Springs, NC seeks a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project. You will drive operational readiness, compliance, training, and continuous improvement at the startup site and transition to post go-live leadership in deviations, RCA, and change controls.

You will shape governance for MES batch records, lead regulatory inspection readiness, and develop a high-performing team focused on excellence and accountability.