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Head CMC Compliance External supply, Due Diligences & Post Merger Integration

Country:  Portugal
City:  Lisbon
Department:  Finance & Controlling
Job ID:  39165

 

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:

 

  • Leading, developing and managing resources of the global team including goal setting and performance review.
  • Responsible for supervising team members wrt designing CMC strategies and providing guidance for operational CMC regulatory support with overall responsibility for the regulatory compliance of supervised product portfolio.
  • Ensure appropriate coordination of GRT Due Diligence Projects for overall GQA with all relevant manufacturing sites and affiliates.
  • Assure proper management of GQA activities resulting out of DD deal closing i.e. assignment, coordination, follow-up to successfully integrate assets in GRT for GQA related topics.
  • Responsible for coordinating appropriate and timely preparation, review and maintenance of CMC sections and other regulatory filings if necessary.
  • Providing guidance for operational CMC regulatory support with overall responsibility for the regulatory compliance of supervised product portfolio including management of changes.

 

What you'll bring to the table:

 

  • Sound experience (5 years plus) in Quality Assurance, Regulatory Compliance and/or Regulatory Affairs as well as in GMP environment.
  • Preferably Pharmacist or other natural scientist degree.
  • Leadership experience of virtual teams, multi-country.
  • Knowledge of relevant national and internal guidelines and regulatory requirements for eg EU, US, LatAm, JPN.
     

 

 

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 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

Your HR contact:
Fabiana Guerra

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

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

Apply now

Apply for Job