Kitchen manager in állások Németországban (egészségügy, gyógyszeripar)

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

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

• 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

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

• Wartung- und Reparaturarbeiten an Hologic Produkten durchzuführen
• An Planungen von Installationen teilzunehmen
• Installation von Geräten kundenseitig durchzuführen
• Kontakt mit IT-Abteilungen der Kunden aufzunehmen und Unterstützung bei der Problembehandlung von Informationssystemen zu gewährleisten

• 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

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• 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

Strategic Account Planning: Own and lead the development and execution of robust, insight-driven key account plans aligned with national brand strategy and local market dynamics....

• Strong leadership to guide the medical team and influence cross-functional collaboration.
• Strategic vision paired with operational agility to deliver in a dynamic, fast-paced environment.

Lead the evolution of the KAM team into a high-performance organization through clear vision, empowerment, coaching excellence, and a culture of continuous learning and improvement, by consistently applying and exemplifying Jazz’s high-performance practices....

Provide comprehensive In-patient clinical case management for a patient where they will be completing status reports upon admission and whilst the patient remains admitted to the provider....

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Support of our subsidiaries, distributors, clinics and patients worldwide
• Technical support for and comprehensive knowledge of the middle ear implant (VIBRANT SOUNDBRIDGE and PMEIs) and the bone conduction solutions (BONEBRIDGE and ADHEAR)

As a Senior Product Portfolio Manager (f/m/x) within ZEISS Meditec AG, your role is similar to and in strong collaboration with product management for the single products contributing to your clinical workflow solution...

The Division of B Cell Immunology studies the molecular and cellular mechanisms affecting the quality of immune responses to vaccination for malaria in preclinical models and humans. The work includes diverse immunological, molecular, cellular, and biochemical assays. In this role, you will plan,...

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations