Chapter Lead Calibration - Drug Substance Basel

Position Overview

Chapter Lead Calibration in Basel Drug Substance Manufacturing, responsible for ensuring calibration and technical support for manufacturing units, reporting to the Unit Head Facilities Management & SHE.

Responsibilities

• Create an environment of strong team spirit, timely communication, high motivation, and inspire teams to achieve goals both immediate and long term.
• Establish strategic goals for the Calibration Chapter, aligning resources to remove impediments, empower self‑organizing teams and drive continuous improvement using PT lean principles.
• Serve as an active change agent on the Facilities Management & SHE leadership team, driving cross‑functional planning, decision‑making and collaboration within the site and across the broader network.
• Maintain full responsibility for the Chapter budget, ensuring strategic allocation of resources and positive impact on the overall financial performance of the FM & SHE Unit.
• Proactively promote a positive Safety Culture and strictly adhere to c GMP operating principles, FDA, OSHA, EPA and SHE regulations.
• Act as the designated Dataset Owner for the Calibration Management System (CCMS), ensuring absolute confidentiality of all process‑related data.
• Ensure timely execution of calibration work orders and first‑level support, guaranteeing all tools and equipment remain within calibration for service and maintenance activities.
• Oversee discrepancy management (per SOP), sponsor structured problem‑solving for deviations, and manage quality approvals including Maintenance Programs, like‑for‑like assessments, Calibration Ranges, Tolerances, and Units of Measure.
• Work closely with internal colleagues, contractors and service engineers to resolve issues efficiently while providing innovative ideas to optimize calibration and troubleshooting practices.

Qualifications

• Graduate degree in Engineering, Biological Sciences or Metrology. Higher‑level degree preferred.
• 10 or more years of experience in the pharmaceutical or related industry, including inspections from health authorities.
• Strong people leader with 6 or more years of people‑management experience.
• 3 or more years of relevant engineering or project‑management experience in the pharmaceutical industry and/or a c GMP environment.
• Deep knowledge of process/equipment parameters of Large Molecule API manufacturing processes.
• Experience with Computerized Calibration Management Systems (CCMS) such as SIMCO, Blue Mountain Quality Resources Regulatory Asset Manager, etc.
• Fluent in German and English.
• Occasional on‑call duty may be required.

Roche is an Equal Opportunity Employer.

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