Quality Strategy Lead, Lifecycle Management (all genders)

Posted 20 Feb 2019

Darmstadt, Hesse - Germany

Req Id 187717

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:  The Quality Strategy Lead, Lifecycle Management will be responsible for developing the design and implementation of risk-based auditing and quality assurance oversight strategy covering the regulated activities in the following areas: Observation/non-interventional studies, Disease/Drug Registries, Epidemiology Studies, Patient Support Programs, Health Outcomes, Real World Data usage, as well as GMA and GRA functional QA support.  As standards and situation continue to develop, you will continually evaluate and modify (as needed) the approach to meet the changing needs of the organization and the regulatory environment. You will build up strong partnership with stakeholder groups across our working environment, provides GCP, GVP expertise and ensure ongoing inspection readiness in the area of responsibility.

 

Who you are:

  • Bachelors in scientific or quality-related subjects required. Advanced degree desirable. Equivalent relevant experience maybe considered
  • Minimum 10 years QA experience or relevant experience in pharmaceutical and/ or biotech industry, in particular clinical quality management, biomedical science, clinical development, or regular compliance with a minimum of 5 years in Clinical / Medical QA
  • Broad working knowledge of other GxP disciplines like  Medical Devices,  GMP or Good Data Management
  • In depth knowledge of drug development process and international GCP regulations and pharmacovigilance guidelines
  • Fluent in written and spoken English

     


What we offer: We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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