Global Quality Product Manager Internal Manufacturing Europe

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like
Each day you´ll enjoy a variety of challenges, such as:

• Planing, defining, compiling and revising and maintaining the quality section of the dossier for Lifecyle product portfolio worldwide
• Proactively developing, in cooperation with eg Production, Quality Control, Regulatory Affairs, other Quality Assurance functions, the global regulatory CMC strategies for active substances and finished products 
• Proactively identify and mitigate potential regulatory risks or roadblocks, developing mitigation plans as needed.
• Ensuring Regulatory Compliance of supervised product portfolio
• Management of Product Change Control for Lifecycle product portfolio
• Providing advice to Grünenthal manufacturing sites, customers and partners regarding global CMC regulatory requirements considering national and international regulatory standards
   

What you´ll bring to the table
To make the most of this role and truly thrive, you should have:

• Degree as a Pharmacist or as other natural scientist
• Profound experience Lifecycle Regulatory CMC for NCEs, knowledge on Medical devices (Drug product combinations) is beneficial
• Proven track record in QA and/or GMP environment especially for Change Management and in depth knowledge of relevant national and international guidelines and regulatory requirements for e.g. US, EU & Japan 
• Experience in critically reviewing detailed scientific information to ensure information is thoroughly assessed, presented clearly and supported by data
• Ability to work in multicultural team
• Decision making also in challenging situations
• Very good oral and written communication skills, especially in English, another language would be a plus, preferably German or Italian or Spanish