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BRBristol Myers Squibb

Associate Director Process Excellence, Launch Operations(m/w/x)

Boudry
Vollzeitmit HomeofficeSenior
AI/ML

Ensuring robust manufacturing processes and technical readiness for new pharmaceutical product launches. Advanced degree in Pharmaceutical Sciences or Engineering, 8+ years pharma manufacturing experience, and French/English fluency required. International environment with global clinical trial participation.

Anforderungen

  • Advanced degree in Pharmaceutical Sciences, Engineering, or related field
  • Minimum 8 years of relevant experience in pharmaceutical manufacturing
  • 5+ years of team leadership experience in pharmaceutical industry
  • Fluency in French and English
  • Proven leadership in technical readiness and continuous improvement projects
  • Knowledge of regulatory requirements and risk management tools
  • Strong working knowledge of GMP and FDA, Eudralex, PICS, and GAMP regulatory requirements
  • Excellent communication, presentation, and collaboration skills
  • Occasional business-related travel required
  • Demonstrated ability to communicate effectively at all levels of the organization
  • Excellent skills to influence stakeholders across functions and hierarchical levels
  • Experience in Lean Manufacturing/Six Sigma
  • Exceptional problem-solving ability
  • Ability to effectively utilize Microsoft Office Suite
  • Knowledge of regulatory requirements and risk management tools
  • Experienced at presenting during regulatory audits (FDA and SwissMedic)
  • CAPEX investment project experience

Aufgaben

  • Lead the Process Excellence team
  • Ensure robust manufacturing processes and compliance
  • Drive technical readiness for new product introductions
  • Manage lifecycle and process optimization
  • Maintain GMP standards and support regulatory requirements
  • Oversee late-stage development priorities and technical transfers
  • Develop and implement the Process Excellence roadmap
  • Foster a coaching and feedback culture within the team
  • Create an environment for accountability and innovation
  • Build technical and compliance capabilities per PU requirements
  • Ensure technical process ownership within the PU
  • Support technical gap assessments and transfer plans
  • Contribute to process technology transfer activities
  • Oversee batch record authoring and MES creation
  • Ensure execution of protocols and reports for new processes
  • Drive lifecycle management initiatives and KPI monitoring
  • Support data analysis for process trends and shifts
  • Provide updates on process performance to management
  • Support regulatory filings and maintain inspection readiness
  • Manage GMP documentation and related KPIs
  • Act as a point of contact for audits and inspections
  • Collaborate with Scheduling, Manufacturing, MS&T, and QA
  • Align with P1 leadership for decision making and best practices
  • Develop training for new products and processes
  • Provide training and support to new Process Excellence associates
  • Promote adherence to Environmental, Health, and Safety standards
  • Manage EHS CAPA and drive safety improvements
  • Lead digital, AI, and innovation projects for the PU
  • Identify opportunities for process and quality improvements

Berufserfahrung

  • 8 Jahre

Ausbildung

  • Master-Abschluss

Sprachen

  • Französischverhandlungssicher
  • Englischverhandlungssicher

Tools & Technologien

  • GMP
  • FDA
  • Lean Manufacturing
  • Six Sigma
  • Microsoft Office Suite
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