Senior Product Quality Expert

​Professional  |  Temporary  |  Full-/ Part-time  |  Hybrid​

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.

This position is offered as a fixed 2-year contract.

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

• Key contributor to Nitrosamine unit concerning regulatory CMC to execute according to applicable international standards in time and quality 
• Conception of planning and interdepartmental coordination for regulatory CMC topics in time and quality including compilation of regulatory CMC Quality work packages
• Proactively developing, in cooperation with eg Quality Control, Regulatory Affairs, other Quality Assurance functions, the global regulatory CMC strategies for active substances and finished products regarding Nitrosamine topics
• Proactively identify and mitigate potential regulatory risks or roadblocks, developing mitigation plans as needed 
• Providing advice to Grünenthal manufacturing sites, customers and partners regarding global CMC regulatory requirements amongst others for Nitrosamines 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 chemist
• Profound experience of Regulatory CMC for NCEs, knowledge on Medical devices (Drug product combinations) is beneficial
• Proven track record in QA and/or GMP environment especially for Nitrosamine related topics, plus in-depth knowledge of relevant national and international guidelines and regulatory requirements for e.g. EU, US & Japan 
• Longstanding experience in Nitrosamine assessments in a multinational pharma company
• Experience in critically reviewing detailed scientific information to ensure information is thoroughly assessed, presented clearly and supported by data