Global Quality Product Manager R&D and Internal Manufacturing (f/m/d)

Country:  Germany
City:  Aachen
Department:  Global Operations & Production
Job ID:  41462

 

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:

  • Issuing, revising and maintaining CMC documentation (IMPD / IND, Module 3 and 2.3) for Medicinal Products for Clinical trial applications and Lifecyle product portfolio
  • Leading of cross functional team responsible for developing chemical-pharmaceutical submission strategies for international Marketing Authorizations including development of standards
  • Working together with R&D and other departments e.g. in GMP environment in cross functional teams driving regulatory CMC topics
  • Management of Product Change Control for R&D and Lifecycle product portfolio
  • Ensuring Regulatory Compliance of supervised portfolio
  • Advising Grünenthal manufacturing sites, customers and partners for CMC topics considering 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 in R&D and Lifecycle Regulatory CMC preferably for NCEs, Biologicals and/or knowledge on Medical devices (Drug product combinations)
  • Sound experience in QA and GMP especially for Change Management and depth knowledge of relevant national and international guidelines and regulatory requirements for e.g. US, EU & Japan
  • Ability to work in multicultural team
  • Decision making also in challenging situations
  • Able to assess processes, identify improvements and implement new efficient solutions
  • Very good communication skills both oral and written skills, especially in English, ideally plus one other language, preferably German

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About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn.

Your HR contact: 
Rita Hugo-Olbertz

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal