Roche
Lead Q&V BGE, Sequencing & LumiraDx
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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
As Lead Q&V for BGE, Sequencing, and LumiraDx within Global Operations, you own end-to-end Q&V strategy and execution across the Sensors & Cartridges (S&C) global network. You align manufacturing and enabling functions while ensuring full regulatory compliance, continuously driving process excellence, and positioning the organization for future readiness.
In this role, you will lead a dedicated team of Q&V professionals, guiding strategy, talent development, process architecture, and cross-functional collaboration across all S&C Global Operations sites.
The Opportunity
- Direct and oversee all Qualification and Validation (Q&V) activities across BGE, Sequencing, and LumiraDx within the S&C global network while aligning departmental strategy with overarching business objectives.
- Ensure full adherence to Standard Operating Procedures (SOPs), the Code of Conduct, and applicable legal, GxP, and industry quality regulations.
- Identify industry trends, technological advancements, and emerging opportunities within the Q&V domain to ensure organizational readiness and continuous evolution.
- Lead, empower, coach, and manage the performance of a team of approximately 15–20 Q&V experts while overseeing workforce planning, strategic resource allocation, and change leadership.
- Design, architect, and implement standardized, harmonized Q&V processes, methods, and tools across all global locations while continuously optimizing workflows.
- Foster transparent stakeholder management and close collaboration with internal partners, including Manufacturing, Automation, MSAT, and QA counterparts across the broader network.
- Establish clear escalation pathways and serve as the primary escalation point for the team to proactively resolve operational bottlenecks and conflicts.
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Who You Are
- Completed Bachelor's or Master's degree in Engineering, Life Sciences, Natural Sciences, or a closely related scientific or technical discipline.
- 6–8 years of relevant experience in the medical device, diagnostic, or pharmaceutical industry, with demonstrated expertise in Qualification and Validation (Q&V) activities.
- Proven track record in direct people management, team development, and guiding cross-functional or global teams through complex projects and organizational change.
- Profound knowledge of legal and regulatory standards (GxP), alongside advanced project management and data analytics skills.
- Business-fluent English for professional negotiations and discussions, with local language proficiency and a willingness to travel internationally considered a plus.
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Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Rotkreuz. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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