Senior kontroller állások Külföldön (egészségügy, gyógyszeripar)

• Manage all lifecycle stages of M&A/PMI projects from the Service perspective, including both Due Diligence as well as Post-Merger Integration projects
• Develop and apply upside potential & risk scenario assessment frameworks for Service

• 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

• Lead and inspire a global team of about 30 scientists and technical experts, fostering innovation, collaboration, and excellence.
• Spearhead the formulation and manufacturing process development for small molecule animal health products, from enabling formulations to tech transfer.

• 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....

• Lead and oversee all clinical safety and vigilance processes for medical devices.
• Manage adverse event assessment and reporting in compliance with global regulations.
• Ensure accurate development and maintenance of RSI, CIP, and IB safety content.

• Master's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering or Law
• Native German speaker with strong English skills (C1)
• 3+ years of experience in GMP deviation & CAPA management
• Strong IT skills

Medical Device Clinical Safety Scientist (m/f/d)- Healthcare/ Scientific/ Biomedical/ MDs/ MD Clinical Investigation/ CIP/ Protocol/ IB/ RSI/ Risk Management/ ISO/ Drug/ English PROJECT: For our customer a big pharmaceutical company in Basel, we are looking for a Medical Device Clinical Safety...

Provide expert leadership and oversight for all clinical safety and vigilance activities associated with Class II and/or III Medical Devices (MD), ensuring adherence to global regulatory requirements and internal standards throughout the product lifecycle....

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• 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

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• 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

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

Austria and Switzerland commercial organisation, Third Party Distributors and relevant external agencies in the execution of the sales and business development strategy ensure accurate and efficient co-ordination and administration of all business...

• 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

• 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 

Develop and implement DSS cross-functional technology infrastructure strategy, ensuring alignment with business needs and stakeholder engagement, including Clinical Data Science, Data Engineering, Statistical Programming and Biostatistics...

• Lead and manage client relationships for pharma and biotech accounts, ensuring satisfaction and longterm partnerships
• Serve as product owner or strategic advisor on key market access projects (AMNOG, EU HTA, pricing, reimbursement)