AEROPHARM GmbH

Site Quality & Global Head Quality Medical Devices (m/w/d)

• Rudolstadt
• Vollzeit
• unbefristet
• mit Berufserfahrung

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz… are you ready to make a difference?

600 million - that's how many people suffer from asthma and COPD worldwide. Many of the innovative medicines are expensive. Sandoz is working hard to offer affordable generics for respiratory diseases.

AEROPHARM GmbH is an innovative pharmaceutical company of the internationally active Novartis AG based in Basel/Switzerland. At its site in Rudolstadt, Thuringia, AEROPHARM GmbH develops and produces cost-effective respiratory medicines for asthma and COPD (chronic obstructive pulmonary disease) with the aim of improving the quality of life of patients worldwide

Ihre Aufgaben

• Responsible for the global deployment and execution of the Quality and Compliance strategy for medical devices to ensure uninterrupted supply. Providing Quality governance in compliance with national and international GxP device regulations and design control standards as well with applicable quality requirements.
• Assures Life Cycle Management activities for commercialized medical devices for Sandoz end to end assuring implementation of the Medical Device Quality strategy.
• Responsible for Medical Device MDR certification and vigilance for Sandoz devices and recall activities per the Sandoz standards and policies. Manages communication and interfaces with external contacts were appropriate: Industry and Health Authorities. External interaction with national and international regulatory bodies (e.g. European Medicines Agency (EMA), Food and Drug Administration (FDA) and Notified Bodies (NBS).
• Responsible for site Quality Assurance, System, Compliance & Quality Control departments of with approximately 46 employees assuring effective and efficient quality management system for drug handling and narcotics, budget, financials, capacity planning and proactively managing WIP and TpT.
• Ensuring compliance with legal regulations (MDR MDR sub ISO 13485 AMG, AMWHV, EUGMP, cGMP, Narcotics...) and to achieve quality objectives (KPls, KQls)

Voraussetzungen

• Master's Degree in Pharmacy or equivalent (PhD preferred)
• Fluency in German is required
• 10-15+ years of international professional experience
in leading positions in the areas of Devices and Quality
(preferably development, production and commercial) with global responsibility.
• Strong People Leadership and Management experience
• Strategic management experience with strong leadership, negotiation persuasion and communication skills
• Proven track record of hosting successful FDA inspections and analytical thinking coupled with solution-oriented and pragmatic action

Was wir bieten

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!