Beschreibung

In this role, you will lead a dynamic team focused on enhancing manufacturing processes and ensuring compliance. Your day-to-day responsibilities will involve driving technical readiness for new products, managing lifecycle initiatives, and fostering a culture of innovation and accountability.

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

Tools & Technologien