Senior Manager, Assembly & Packaging Start-Up Lead

F. Hoffmann-La Roche AG

Holly Springs (MS)

On-site

USD 116,000 - 217,000

Full time

3 days ago

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Benefits offered by this job

Relocation assistance

Annual bonus

Job summary

Genentech, a member of the Roche group, seeks a Senior Manager to lead the Assembly and Packaging Process and Compliance team at the Holly Springs site. You will manage operational readiness, regulatory readiness, and continuous improvement for SOPs, deviations, and change controls.

The role requires 12+ years in bio/pharma manufacturing, strong RCA skills, and proven cross-functional leadership across Operations, QA, and Safety.

Qualifications

BS/MS in Science or Engineering with 12+ years in bio/pharma manufacturing, quality, or engineering.
Experience with device assembly, packaging equipment, and materials/components.
5+ years as deviation owner using RCA tools such as 5 Whys, Fault Tree Analysis, and Fishbone.
2+ years managing change controls.
Strong cross-functional collaboration across Operations, QA, Supply Chain, Safety, etc.

Responsibilities

Oversee SOPs, work instructions, and critical documentation for Assembly and Packaging.
Drive proactive risk management plans prior to operational impact.
Govern MES batch records validation and approval framework.
Lead learning and technical capability development for the A&P team.
Direct investigation governance for major/minor deviations and third-party nonconformances.
Lead change controls and regulatory inspections readiness as site SME.
Mentor and build high-performing A&P team post go-live.