Technischer manager állások Németországban (minőségbiztosítás)

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

• 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

• 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

• 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

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

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)...

• 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

• 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

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

• Coordinate alliance management activities and ensure adherence to contractual commitments
• Support (and later) lead contract-related updates, including tracking and initiating required changes
• Contribute to achieving key alliance business objectives

• Operate as the primary point of contact taking comprehensive care of the needs of our customers around the world
• Ensure premium customer care through regular, remote and on-site Business Review Meetings (BRM) as well as leading Weekly Business Meetings (WBM)