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F.F. Hoffmann-La Roche AG

.Global Fleet Program Owner(m/w/x)

Basel
Full-timeOn-siteSenior
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Global fleet program ownership for DS and DP equipment standards. Strategic leadership and standardization champion required. Oversight for fleet concept implementation and technical change governance.

Requirements

  • Strategic leadership and standardization champion
  • Ability to drive alignment across diverse groups
  • Excellent communication skills
  • Decisive accountability for manufacturing systems
  • High degree of technical integrity
  • Precision in managing complex changes
  • Ensuring global equivalency in regulated environment
  • Master’s degree in Engineering, Life Sciences, or related technical field
  • PhD is a plus
  • Minimum 10 years pharmaceutical/biotech experience
  • Focus on multi-site operations and system standardization
  • Deep expertise in managing complex equipment lifecycle
  • Strong understanding of GMP
  • Strong understanding of Quality Systems (PQS)
  • Strong understanding of global regulatory requirements (ICH Q10, ICH Q12)
  • Proven track record in leading change management
  • Performing cross-site impact assessments in GMP environment
  • Exceptional leadership skills
  • Ability to influence decision-making
  • Drive results across engineering, quality, site leadership

Tasks

  • Champion the 'design one, build many' philosophy
  • Provide strategic and operational oversight for fleet concept implementation
  • Act as single point of accountability for DS and DP fleet equipment standards
  • Establish and maintain robust governance for technical changes
  • Approve comparative analyses of GMP-critical and process-critical systems
  • Serve as primary contact for health authority interactions
  • Manage master inventory and status of fleet equipment
  • Own global lifecycle deliverables including validation plans, SOPs, and URS
  • Lead impact analysis for changes to ensure consistent implementation
  • Decide on new technical requirements and deployment timelines

Work Experience

  • 10 years

Education

  • Master's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • GMP
  • Quality Systems (PQS)
  • ICH Q10
  • ICH Q12
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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