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F.F. Hoffmann-La Roche AG

Commissioning & Qualification Regional Lead(m/w/x)

Basel
Full-timeOn-siteSenior
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Developing C&Q strategy for global pharmaceutical projects, ensuring alignment with ISO standards. Strategic systems thinking and executive presence required. Overseeing project cost estimates and C&Q schedules.

Requirements

  • Strategic systems thinking
  • Strong drive for execution
  • Compliance-focused mindset
  • Exceptional executive presence
  • Ability to navigate complex organizational dynamics
  • Influencing senior partners and stakeholders
  • Passion for innovation and collaboration
  • Building organizational capability
  • Motivating diverse technical teams
  • University Degree in Engineering, Science, or related discipline
  • At least 10 years experience in biopharmaceutical industry
  • Vast experience in Commissioning, Qualification, and Validation (CQV)
  • Experience with sterile manufacturing, utilities, facilities, and automation systems
  • In-depth knowledge of global regulations (FDA, EMA, ICH)
  • Application of industry best practices within GMP environment
  • Proven track record leading regional functions
  • Managing portfolio of large-scale capital projects
  • Strong business and financial acumen
  • Experience in contract negotiations
  • Managing strategic service provider relationships
  • Ability to drive change and standardize processes
  • Implementation of systems like eVal Roche
  • Flexibility and willingness to travel approximately 20% - 30%
  • Potential short-term assignments at project sites

Tasks

  • Oversee C&Q strategy development
  • Ensure alignment with global standards
  • Integrate lessons learned
  • Review project cost estimates
  • Establish robust C&Q schedules
  • Mitigate business risk
  • Drive internal resource planning
  • Collaborate on long-term staff development
  • Organize C&Q workshops
  • Integrate new knowledge
  • Feed improvements into global processes
  • Ensure robust monthly reporting
  • Track project status
  • Identify and escalate project risks
  • Perform C&Q peer reviews
  • Evaluate project status
  • Ensure compliance across equipment lifecycle
  • Monitor global industry trends
  • Implement innovative qualification processes
  • Drive sustainable and cost-effective practices

Work Experience

  • 10 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • eVal Roche
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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