Senior manager állások Külföldön (egészségügy, gyógyszeripar)

• Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
• Manage the development and implementation of RA strategies
• Support and prepare product submission documents with main focus on US
• Partner with business stakeholders on different levels

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

Act as the primary IT business partner for the R&D organization, aligning IT initiatives with R&D strategy, priorities, and the strategic demand management process....

• Own and achieve order and sales targets in the designated sales territory and accounts.
• Promote the full Leica Biosystems product and services portfolio through customer visits and relationship building.

Partner and develop ongoing relationships and value propositions within the C-suite at the HQ LNG as well as key stakeholders within the different accounts dedicated to the LNG (i/e Committee Members, Procurement, Medical Directors etc.)...

QA MANAGER - DRUG PRODUCT CLINICAL MANUFACTURING (M/F/D) - QUALITY ASSURANCE / PHARMACEUTICAL / CGMP / SYNTHETIC MOLECULES / GMP AUDITS / SAP / VEEVA / GERMAN / ENGLISH PROJECT: For our client, a large pharmaceutical company based in Basel, we are looking for a QA Manager (m/f/d) Drug Product...

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

• Take full responsibility for the product portfolio throughout its entire lifecycle - from concept to phase-out
• Derive market and customer needs and translate them into clear product requirements and strategies

Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation....

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Become an expert in Brainlab's orthopedic planning and endovascular navigation portfolio
• Demonstrate solutions both in person and online, showcasing clinical value through interactive demos, workshops, and webinars

• Play an important role within in a multidisciplinary team in the development of new and complex products / segments / features and in the management throughout the entire life cycle
• Create product visions and/or strategies independently for complex products / segments / features

Monitor and execute the data operations and data quality process. May include coordination of testing, error handling, data conversion and/or validation, and audit/compliance actions (Non-Conformance (NC) and/or Corrective Action Preventive Action (CAPA)). Provide tactical direction to third party...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...