Pre-clinical / Clinical QA Manager - Auditor (f/m/d) limited to 12 months

Country:  Europe
City:  Europe
Department:  Global Operations & Production
Job ID:  41338

 

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:

  • Planning, preparing, conducting - remotely and on site - and reporting audits from the clinical annual audit program (includes Investigator Site, Contract Research Organisation and external supplier audits)
  • Ideally, performing audits from the pre-clinical annual audit program
  • Summarizing outcomes of audits and developing and presenting recommendations to improve quality, compliance and performance
  • Checking and aligning the CAPA plans of the auditees and monitor the execution.
  • Facilitating and contributing to the strategic development of an risk-based clinical and pre-clinical annual audit program and supplier quality management program, designed to improve their standards and compliance status
  • Setting up, negotiating and maintaining Quality Agreements
  • Ensuring that audits comply with the principles of GCP or GLP, respectively, and are undertaken in line with applicable regulatory requirements and organizational priorities and standards.
  • Identifying and mitigating quality and compliance issues and promote lessons-learned


What you´ll bring to the table
To make the most of this role and truly thrive, you should have:

  • A MSc in Natural Science, Pharmacy or have a comparable degree / adequate education or performed as a Medical Doctor
  • You are an experienced senior auditor in the clinical and ideally in the preclinical area, able to understand and audit in depth computerized Systems, too.
  • Depth knowledge and extensive experience throughout all stages of clinical development and clinical trial conduct (e. g. as Quality Manager, CRA, Project manager of clinical trials, auditor, clinical scientist or data manager)
  • Ideally depth knowledge and extensive experience throughout all stages of pre-clinical development and pre-clinical study conduct (e. g. as Quality Manager, Study Director, Study Monitor).
  • You know in depth GCP and ideally GLP regulations and guidelines
  • Team spirit and have strong interpersonal skills to collaborate in a highly matrixed and highly outsourced model
  • Advanced negotiation skills and are able to manage suppliers remotely
  • Performance and strong problem solving, stakeholder management and excellent communication skills
  • Fluent business English language skills in speaking and writing, German language skills are beneficial
  • Willingness to travel worldwide

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"Quality from the beginning. In this function you play an important role in ensuring that our Research & Development Partners deliver according to the applicable standards and improve every day."

Astrid Kuth, the Hiring Manager

 

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