Senior Manager, Assembly & Packaging - Go‑Live Leader

NCBioImpact; Holly Springs (NC); Sur place; USD 116 000 - 217 000; Plein temps

Avantages offerts par ce poste

Relocation benefits

Résumé du poste

Genentech in Holly Springs, NC seeks a Senior Manager to lead the Assembly and Packaging Process & Compliance team for the Apollo 11 project. You will steer operational readiness, change controls, deviation management, and regulatory readiness during startup and post go-live phases.

You will mentor cross-functional teams across Operations, Engineering, QA, Supply Chain, Safety, and other departments to deliver quality, compliant, and efficient manufacturing of high-volume biologics.

Qualifications

• 12+ years in bio/pharmaceutical manufacturing, quality, or engineering.
• 5+ years as a deviation owner using RCA tools (5 Whys, Fishbone, FTA).
• 2+ years in change controls.
• Experience in FDA-regulated bio/pharma environments and cGMP.
• Strong cross-functional collaboration across Ops, Eng, QA, Supply Chain.

Responsabilités

• Oversee SOPs, work instructions, and critical documentation for Assembly and Packaging.
• Drive risk management and strategic mitigation before operational impact.
• Govern MES batch records validation, approval framework, and data integrity.
• Lead learning and technical capability development for the A&P team.
• Direct deviation investigations and third-party nonconformances.
• Lead change controls and regulatory inspection readiness.
• Post go-live, mentor the P&C team and drive ongoing process improvements.

Connaissances

Cross-functional leadership

Regulatory readiness

Root cause analysis

Project management

Change control leadership

Operational excellence

Formation

BS/MS in Science or Engineering

Outils

Veeva QMS

Veeva QDocs

Description du poste

Genentech in Holly Springs, NC seeks a Senior Manager to lead the Assembly and Packaging Process & Compliance team for the Apollo 11 project. You will steer operational readiness, change controls, deviation management, and regulatory readiness during startup and post go-live phases.

You will mentor cross-functional teams across Operations, Engineering, QA, Supply Chain, Safety, and other departments to deliver quality, compliant, and efficient manufacturing of high-volume biologics.