Senior C&Q Leader for GMP Capital Projects

F. Hoffmann-La Roche AG; Hillsboro (OR); On-site; USD 109,000 - 204,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech is seeking a Commissioning & Qualification Manager to lead cross‑functional teams through C&Q delivery for GMP facilities, ensuring compliant, on‑time, and on‑budget execution while maintaining the highest standards of quality and safety.

You will manage options analysis, detailed execution, contractor oversight, and safety programs, aligning with Roche standards and regulatory requirements to enable global manufacturing of life‑changing medicines.

Qualifications

• Bachelor's degree in Engineering, Quantity Surveying, or related field.
• 8+ years of capital project management, Commissioning, Qualification, and Validation in pharma/biopharmaceutical environments.
• Deep regulatory knowledge (FDA/EMA/ICH) and GMP facility experience.

Responsibilities

• Lead cross-functional, matrixed C&Q project teams to ensure scope, budget, and schedule adherence.
• Develop and execute C&Q strategies aligned with ASTM E2500 and risk-based approaches.
• Coordinate with project management, manufacturing operations, quality, site leadership, and external contractors.
• Oversee options analysis, planning, detailed execution, contractor oversight, safety programs, and handover.
• Monitor project performance, provide regular status updates, and drive corrective actions to stay on time and on budget.
• Mentor and manage C&Q team members and external contractors, ensuring contractual and behavioral accountability.
• Champion best practices in C&Q project management and continuous improvements across the organization.

Skills

Cross-functional leadership

Communication

Team-building

Project management

Regulatory knowledge

GMP knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Genentech is seeking a Commissioning & Qualification Manager to lead cross‑functional teams through C&Q delivery for GMP facilities, ensuring compliant, on‑time, and on‑budget execution while maintaining the highest standards of quality and safety.

You will manage options analysis, detailed execution, contractor oversight, and safety programs, aligning with Roche standards and regulatory requirements to enable global manufacturing of life‑changing medicines.