Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
At Roche, over 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel Drug Substance Manufacturing with its 600 employees produces Large Molecule APIs (Active Pharmaceutical Ingredients) for commercial and clinical supply.
As Chapter Lead Calibration you enable and empower your team to deliver our vision through embedding new ways of working, demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviors. You and your team are maintaining the site’s right to operate and enable excellence in manufacturing by providing technical support to Manufacturing Units in Basel DS resulting in safe, high quality, and continuously improving production as well as technical transfers.
You serve both, our patients and our employees in the Units on site by developing and implementing process improvements, foster the dialogue and collaboration between global functions in development, innovation and regulatory and align across other Roche manufacturing sites. You will be part of the Facilities Management& SHE Leadership Team and report to the Unit Head Facilities Management& SHE.
The Opportunity:
You create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Furthermore:
- Strategic Leadership& Vision: Establish strategic goals for the Calibration Chapter, aligning resources to remove impediments, empower self-organizing teams, and drive a continuous improvement mindset using PT lean principles
- Network& Site Collaboration: Serve as an active change agent on the FM leadership team, driving cross-functional planning, decision-making, and collaboration both within the site and across the broader network
- Financial Accountability: Maintain full responsibility for the Chapter budget, ensuring strategic allocation of resources and a positive impact on the overall financial performance of the FM Unit
- Safety& Compliance Culture: Proactively promote a positive Safety Culture and strictly adhere to cGMP operating principles, as well as regulatory compliance requirements from the FDA, OSHA, EPA, and SHE regulations
- Data Ownership& Confidentiality: Act as the designated Dataset Owner for the Calibration Management System (CCMS), ensuring absolute confidentiality of all process-related data
- Operational Excellence& Execution: Ensure the timely execution of calibration work orders and 1st-level support, guaranteeing all tools and equipment remain within calibration for service and maintenance activities
- Quality Assurance& Problem Solving: Oversee Discrepancy Management (per SOP), sponsor structured problem-solving for deviations (OOT), and manage quality approvals including Maintenance Programs, like-for-like assessments, Calibration Ranges, Tolerances, and Units of Measure
- Continuous Optimization& Collaboration: Work closely with internal colleagues, contractors, and service engineers to resolve issues efficiently while constantly providing innovative ideas to optimize calibration and troubleshooting practices
Who You Are:
You have a Graduate Degree (Engineering, Biological Sciences, or Metrology) or higher-level Degree is preferred. Furthermore:
- 10 or more years work experience in the pharmaceutical or related industry, including inspections from Health Authorities
- Strong people leader ability with 6 or more years people management experience
- 3 or more years relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment
- Deep knowledge in Process/Equipment Parameters of Large Molecule API manufacturing processes.
- Computerized Calibration Management Systems (CCMS), including but not limited to SIMCO, Blue Mountain Quality Resources’ Regulatory Asset Manager, etc.
- Fluent in German and English is a must
- Occasional on-call duty may be required
Sounds interesting? Apply now!
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
