Roche
Pharmaceutical
Commissioning&QualificationManager(m/f/d)
Neural analysis suggests this role is
optimal for Mid candidates.
“Commissioning & Qualification Manager (m/f/d) at Roche. Skills: Commissioning, Qualification, Project Management, Global Compliance. Lead Cross-Functional Teams. Drive Project Success”
What You'll Achieve.
Compliant, in time and in budget delivery of Commissioning & Qualification deliverables; Deliver life-saving medicines to patients worldwide
Industry & Context.
Travel (20%) may be required, Spend most of the time on site if assigned to a project during design or construction
What They're Looking For.
Must Have
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, Experience leading the commissioning and qualification of packaging and autoinjector assembly, Experience in the commissioning and qualification of cleanroom systems, Deep knowledge of C&Q strategies (ASTM E2500), Deep knowledge of risk-based approaches, Deep knowledge of global regulations (FDA, EMA, ICH), Proficient in both German and English (written and spoken)
Nice to Have
Travel (20%) may be required, Expectation if assigned to a specific project during design or construction it is required to spend most of the time on site
What You'll Do.
Lead Cross-Functional Teams
Drive Project Success
Ensure Global Compliance
Innovate and Challenge
Partner Strategically
How You'll Work.
Team & Collaboration
Lead diverse, cross-functional teams; Motivate and inspire diverse teams; Build trustful relationships with key stakeholders and customers
Communication Scope
Ability to adjust style to various audiences
Process & Methodology
Sub-Project Manager, Manage C&Q project scope, Deliver C&Q deliverables, Capex project management
Full Job Description
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 both 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. You will: * **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
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