Commissioning & Qualification Manager (m/f/d)

As a C&Q Manager within Global Engineering, you will be responsible for the compliant, timely, and budget-conscious delivery of Commissioning & Qualification projects for Roche's pharmaceutical technical operations. You will lead cross-functional teams, drive project success, ensure alignment with global quality and regulatory standards, and implement innovative best practices.

Responsibilities

• Lead and motivate diverse cross-functional teams to foster a collaborative culture.
• Manage project scope to ensure deliverables meet budget and schedule requirements.
• Execute all activities in alignment with the Roche Pharmaceutical Quality Management System and international regulatory standards.
• Identify and implement innovative best practices for C&Q Capex project management.
• Build strategic relationships with stakeholders to support business goals.

Requirements

• University degree in Engineering, Science, or a related discipline.
• 5-8 years of experience in the biopharmaceutical industry, specifically in sterile drug product manufacturing or qualification.
• Proven experience in leading C&Q for sterile filling facilities, packaging, autoinjector assembly, and cleanroom systems.
• Deep knowledge of C&Q strategies (ASTM E2500), risk-based approaches, and global regulations (FDA, EMA, ICH).
• Proficiency in both German and English.