Senior CMC & Quality Manager
Grünenthal Group
Multiple Locations, Europe
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 e.g. 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.
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