Global GMP C&Q Project Leader

Genentech; Hillsboro (OR); Presencial; USD 109 000 - 204 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Relocation benefits

On-site position

Resumo da oferta

Genentech is seeking a Commissioning & Qualification Manager to lead cross-functional teams through C&Q delivery for capital projects, ensuring compliance with Roche PQS, Engineering Manual, and applicable regulations. You will manage scope, budget, and schedule, while driving risk-based strategies and vendor oversight to deliver GMP-ready facilities and systems for global operations.

You will partner with project management, manufacturing operations, quality, site leadership, and external

Qualificações

• Bachelor's degree in Engineering or related field with 8+ years of capital project management experience, Commissioning, Qualification, and Validation in pharma/biopharma environments.
• Strong leadership of cross‑functional teams with excellent collaboration and communication.
• Deep regulatory knowledge (FDA, EMA, ICH) and GMP facility experience.

Responsabilidades

• Lead cross-functional C&Q project teams and set expectations for scope, budget, and schedule.
• Develop and execute C&Q strategies aligned with risk-based approaches and detailed work plans.
• Coordinate with PM, manufacturing ops, quality, site leadership, and external contractors for integrated execution.

Conhecimentos

Leadership

Cross-functional collaboration

PM/Project management

Regulatory knowledge

Communication

Formação académica

Bachelor's degree in Engineering or related field

Descrição da oferta de emprego

Genentech is seeking a Commissioning & Qualification Manager to lead cross-functional teams through C&Q delivery for capital projects, ensuring compliance with Roche PQS, Engineering Manual, and applicable regulations. You will manage scope, budget, and schedule, while driving risk-based strategies and vendor oversight to deliver GMP-ready facilities and systems for global operations.

You will partner with project management, manufacturing operations, quality, site leadership, and external