Senior CMC & Quality Manager

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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