Senior system engineer állások Svájcban (egészségügy, gyógyszeripar)

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

• Market & Revenue Development: Implement market entry strategies and acquire international patients (B2C) as well as strategic partners (B2B)
• Market Analysis: Conduct market research, evaluate opportunities, and assess regulatory and competitive landscapes

Networking - You enjoy maintaining and expanding your network of decision-makers in the healthcare industry. You utilise your contacts to generate leads and gather information....

• Design, develop, and optimize coagulation diagnostic assays and reagents
• Lead feasibility studies, verification, and validation activities in compliance with ISOand IVDR requirements
• Document all activities according to quality system procedures and design control standards

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• Develop and validate LC-MS methods for the quantification of impurities in complex samples
• Optimize and troubleshoot analytical methods to ensure accuracy, precision and robustness 
• Collaborate closely with cross-functional teams to drive project success

• Interface between construction site and operator
• Support for the existing SHE organization (operator)
• Issuing work permits to contractors
• Monitoring compliance with relevant safety regulations
• Participation in coordination and construction meetings
• Safety inspections as needed

• Lead strategic sourcing and CDMO site selection, including due diligence
• Conduct price negotiations and manage contracting of CMO agreements
• Drive Supplier Relationship Management (SRM) activities for CMOs
• Develop and operationalize category strategies, buying guides, and best practices

• Strategic Sourcing / CDMO Site Selections including Due Diligence
• Price Negotiation
• Contracting of CMO contracts
• SRM Activities for CMOs
• University degree a scientific or business field or similar
• Min. 5 years relevant experience CMO Management or procurement in CMO space 
• GMP Experience 

• Ensure compliance of manufacturing processes, batch records, deviations, change control, and CAPA.
• Review and approve executed batch records within defined timelines.
• Responsible for technical batch release.
• Provide active on-the-floor support.

• Manage complex calendars to ensure effective prioritization and alignment with business needs, including scheduling, travel, correspondence, and meeting logistics.
• Coordinate and prepare briefing materials, presentations, and reports for internal and external meetings.

• Lead, coach, and inspire a global team of Programme Managers - fostering collaboration, accountability, and continuous development
• Oversee customer account allocation and ensure balanced workload distribution and high-quality delivery across the team