Dein persönlicher KI-Karriere-Agent
Associate Director Process Excellence, Launch Operations(m/w/x)
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
- Französisch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- FDA
- Lean Manufacturing
- Six Sigma
- Microsoft Office Suite
Noch nicht perfekt?
- Bristol Myers SquibbVollzeitmit HomeofficeManagementBoudry
- 1112 Celgene International SaRL
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Associate Director Process Excellence, Launch Operations(m/w/x)
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
- Französisch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- FDA
- Lean Manufacturing
- Six Sigma
- Microsoft Office Suite
Über das Unternehmen
Bristol Myers Squibb
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
Noch nicht perfekt?
- Bristol Myers Squibb
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