Roche Diagnostics Int. AG
Global Ops Strategy Lead(m/w/x)
Vollzeitnur vor OrtSenior
Risch-Rotkreuz
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RORoche Diagnostics Int. AG
Lead Q&V BGE, Sequencing & LumiraDx(m/w/x)
VollzeitVor OrtSenior
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Developing Q&V strategy for BGE, Sequencing, and LumiraDx diagnostic products. 6-8 years medical device Q&V experience and people management required. Focus on regulatory compliance and process excellence.
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Anforderungen
- Bachelor's or Master's degree in Engineering, Life Sciences, Natural Sciences, or related technical discipline
- 6–8 years relevant experience in medical device, diagnostic, or pharmaceutical industry
- Demonstrated expertise in Qualification and Validation (Q&V) activities
- Proven track record in direct people management
- Team development skills
- Guiding cross-functional or global teams through complex projects and organizational change
- Profound knowledge of legal and regulatory standards (GxP)
- Advanced project management skills
- Advanced data analytics skills
- Business-fluent English for professional negotiations and discussions
- Local language proficiency considered a plus
- Willingness to travel internationally considered a plus
Aufgaben
- Own end-to-end Q&V strategy and execution for BGE, Sequencing, and LumiraDx
- Align manufacturing and enabling functions with Q&V strategy
- Ensure full regulatory compliance for Q&V activities
- Continuously drive process excellence in Q&V
- Position the organization for future readiness in Q&V
- Lead a dedicated team of Q&V professionals
- Guide Q&V strategy, talent development, and process architecture
- Oversee cross-functional collaboration across S&C Global Operations sites
- Direct and oversee all Qualification and Validation (Q&V) activities
- Align departmental strategy with overarching business objectives
- Ensure adherence to SOPs, Code of Conduct, and quality regulations
- Identify industry trends and technological advancements in Q&V
- Empower, coach, and manage the performance of Q&V experts
- Oversee workforce planning and strategic resource allocation
- Lead change initiatives within the Q&V team
- Design, architect, and implement standardized Q&V processes
- Optimize Q&V workflows across global locations
- Foster transparent stakeholder management and collaboration
- Collaborate with Manufacturing, Automation, MSAT, and QA counterparts
- Establish clear escalation pathways
- Serve as the primary escalation point for the Q&V team
- Proactively resolve operational bottlenecks and conflicts
Berufserfahrung
6 - 8 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
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The company is dedicated to advancing personalized medicine and improving patient lives through innovative diagnostics and healthcare solutions.
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