Plant Startup Lead — Assembly & Packaging Excellence

Genentech; Holly Springs (NC); On-site; USD 116,000 - 217,000; Full time

Job summary

Genentech in Holly Springs, NC seeks a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project. The successful candidate will drive operational readiness, compliance, training, and continuous improvement for A&P functions at the site.

Post go-live, you will transition to lead the P&C Business Unit, mentoring the team and overseeing deviations, change controls, and regulatory inspections with strong cross-functional collaboration across Operations,

Qualifications

• 12+ years of deep bio/pharmaceutical manufacturing, quality, or engineering experience.
• Practical knowledge of device assembly and packaging equipment, processes, and materials/components.
• 5+ years experience as a deviation owner, using RCA tools such as 5 Whys, Fault Tree Analysis and Fishbone.
• 2+ years experience managing change controls.
• Demonstrated ability to lead cross-functional teams and collaborate across Operations, Engineering, QA, Supply Chain, Safety.

Responsibilities

• Oversee SOPs, work instructions, and critical documentation for Assembly and Packaging.
• Drive risk management initiatives to identify operational risks and mitigate before impact.
• Provide governance for MES batch records and validation approvals.
• Lead learning and technical capability development across the A&P team.

Skills

Cross-functional leadership

Root cause analysis

Change control management

FDA regulated environment

Deviations ownership

Education

BS/MS in Science or Engineering

Tools

Veeva QMS

Veeva QDocs

Job description

Genentech in Holly Springs, NC seeks a Senior Manager to lead the Assembly and Packaging Process and Compliance Team for the Apollo 11 project. The successful candidate will drive operational readiness, compliance, training, and continuous improvement for A&P functions at the site.

Post go-live, you will transition to lead the P&C Business Unit, mentoring the team and overseeing deviations, change controls, and regulatory inspections with strong cross-functional collaboration across Operations,