Chapter Lead Calibration Drug Substance Basel

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

At Roche over 100000 people across 100 countries are pushing back the frontiers of healthcare. Working together weve become one of the worlds 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 sites 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&SHE 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&SHE 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!

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Employment Type : Full-Time
Experience: years
Vacancy: 1