TRIGA Consulting GmbH & Co. KG

• Fachliche und disziplinarische Führung eines Teams von ca. 50 Mitarbeitenden, inklusive 3 Führungskräfte auf Head-Level • Gesamtverantwortung für die Weiterentwicklung der globalen Product-Operations-Funktion sowie Sicherstellung effizienter und regulatorisch konformer Qualitätsprozesse • Verantwortung für die Steuerung und kontinuierliche Optimierung qualitätsrelevanter End-to-End-Prozesse entlang des Produktlebenszyklus • Überwachung und Steuerung von Marktbeanstandungen, Reklamationen und Rückrufaktivitäten unter Berücksichtigung regulatorischer Anforderungen und wirtschaftlicher Auswirkungen • Zentrale Ansprechperson für qualitätsrelevante Eskalationen sowie Koordination bereichsübergreifender Lösungs- und Entscheidungsprozesse • Durchführung und Bewertung von Risikoanalysen sowie Ableitung geeigneter Maßnahmen zur Risikominimierung • Sicherstellung der Einhaltung internationaler regulatorischer Anforderungen sowie relevanter GMP- und GDP-Richtlinien • Entwicklung und Implementierung nachhaltiger Maßnahmen zur kontinuierlichen Verbesserung von Prozessen, Strukturen und Qualitätsstandards • Verantwortung für Budgetplanung, Ressourcensteuerung und Priorisierung innerhalb des Verantwortungsbereichs • Enge Zusammenarbeit mit den Bereichen Quality Assurance, Regulatory Affairs, Pharmacovigilance, Supply Chain, Manufacturing sowie weiteren internationalen Schnittstellen • Aufbau und Pflege langfristiger Beziehungen zu internen und externen Stakeholdern, Dienstleistern und Behörden • Förderung innovativer Ansätze sowie Nutzung moderner digitaler Lösungen zur weiteren Professionalisierung und Effizienzsteigerung der Organisation

• Manage the EU regulatory strategy across all clinical development phases • Own programs from first-in-human through to market approval • Lead Scientific Advice and strategic communications with regulatory authorities • Translate complex requirements into clear regulatory action plans • Oversee clinical trial applications (CTAs) and major amendment procedures • Identify regulatory risks early and define concrete mitigation measures • Ensure high-quality and consistent submission documentation • Proactively shape regulatory strategies in the ATMP space • Work closely with cross-functional teams • Help prevent regulatory risks in late-stage development

• Lead the EU CMC strategy for multiple clinical programs • Translate technical changes into regulatory robust strategies • Develop solutions for comparability, specifications and process changes • Identify regulatory risks early and define pragmatic mitigation measures • Lead CMC activities for clinical trial applications and amendments • Prepare structured, high-quality submission documentation • Design strategies for communications with regulatory authorities • Prepare for and support interactions with EU authorities • Ensure regulatory compliance of external manufacturing partners • Work closely with Quality and technical functions • Actively monitor regulatory developments in the CMC space • Contribute to the advancement of regulatory standards within the company

• Functional and disciplinary leadership of an international Quality team of approximately 20 employees, including direct line management of a Head-level position. • Overall responsibility for global quality assurance in collaboration with contract manufacturers (CMOs), suppliers, and strategic partners. • Development and implementation of the global quality strategy for CMO and partner management, taking into account regulatory requirements and company objectives. • Ensure that external collaborations are managed efficiently within defined quality and control frameworks. • Oversee and prioritize quality-relevant activities across the international partner and supplier network. • Responsible for planning, monitoring, and adherence to quality-related budgets within the area of responsibility. • Ensure compliance with international regulatory standards and internal quality requirements. • Provide operational support on complex quality issues in collaboration with external manufacturers and partners. • Drive the development and optimization of quality-related processes and plan and conduct internal and external audits to ensure regulatory compliance. • Evaluate and audit contract manufacturers and identify and mitigate potential risks in manufacturing processes.

• Technical and disciplinary leadership of a Quality team of approximately 8–10 employees within a defined indication. • Overall responsibility for all product-related quality activities across the entire product lifecycle. • Development and implementation of an overarching quality strategy for the responsible portfolio and ensuring effective deployment into operational structures. • Active contribution to product strategy from a quality perspective in coordination with relevant interface functions. • Ensuring patient safety and regulatory compliance, taking into account national and international requirements. • Responsibility for quality risk management including identification, assessment, and control of quality-related risks. • Establishment of appropriate measures for early detection of errors and initiation of sustainable improvement actions. • Central point of contact for quality-related escalations within the portfolio and coordination of cross-departmental solution processes. • Management and engagement of relevant internal and external stakeholders to ensure efficient processes for quality-critical issues. • Monitoring quality-related metrics and deriving appropriate actions for continuous optimization of product and process quality.