Commissioning & Qualification Manager (m/f/d)

• Commissioning & Qualification Manager (m/f/d)
• Mannheim

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive personally and professionally.

This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters.

The Position

Global Engineering executes projects in Pharma Technical Operations (PT), and other divisions within Roche on demand.

Within Global Engineering, the Commissioning & Qualification (C&Q) Manager has overall responsibility for the compliant, in time and in budget delivery of Commissioning & Qualification deliverables.

The Commissioning & Qualification Manager reports to the PTT Regional Head of C&Q.

Work is self‑directed in nature.

Projects / initiatives can vary in both length of time and complexity, requiring extensive cross‑functional collaboration and agile execution strategies in support of GMP manufacturing operations, affiliates and CMOs.

The position requires excellent internal and external collaboration and influencing skills and the ability to lead diverse, cross‑functional teams.

Are you ready to lead large-scale engineering projects that deliver life‑saving medicines to patients worldwide?

Join our Global Engineering team and take overall responsibility for the compliant and timely delivery of Commissioning & Qualification (C&Q) for our pharmaceutical technical operations.

The Opportunity

As a C&Q Manager, you will act as a Sub‑Project Manager within Global Engineering, driving excellence in a dynamic and collaborative team environment.

• Your responsibilities
• Lead Cross‑Functional Teams: motivate and inspire diverse teams during the C&Q phase, setting clear expectations and fostering a "one team" culture.
• Drive Project Success: manage C&Q project scope to ensure deliverables are met within the approved budget and schedule.
• Ensure Global Compliance: execute all deliverables in full alignment with the Roche Pharmaceutical Quality Management System (PQS) and international regulatory standards.
• Innovate and Challenge: identify better ways to accomplish objectives by introducing best practices and innovation for C&Q Capex project management.
• Partner Strategically: proactively build trustful relationships with key stakeholders and customers to support Roche’s strategic business goals.

Qualifications

• A University Degree in Engineering, Science, or a related discipline.
• Bachelor with 6‑8 years experience, Master with 5‑7 years experience in the (bio)pharmaceutical industry, specifically in sterile drug product manufacturing or qualification.
• Experience in leading a drug product sterile filling facility commissioning and qualification, leading the commissioning and qualification of packaging and autoinjector assembly, as well as in the commissioning and qualification of cleanroom systems.
• Deep knowledge of C&Q strategies (ASTM E2500), risk‑based approaches, and global regulations (FDA, EMA, ICH).
• Proficient in both German and English (written and spoken) with the ability to adjust your style to various audiences.
• Travel (20%) may be required to meet the business need, in order to lead the team at the project site/location.

Expectation if assigned to a specific project during design or construction it is required to spend most of the time on site.

This is a 100% full‑time role and locally based in potential future EU sites and/or Mannheim / Penzberg.

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