Associate Director, Computerized System Validation (all genders)

Posted 11 Nov 2019

Darmstadt, Hesse - Germany

Req Id 199780

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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 tasks:

You will be responsible to define the Quality IT validation strategy for the deployment and maintenance of Electronic Quality Systems for GMP/GDP related activities of Global Healthcare Operations. You will assure the 21CFR part 11 and EU GMP Annex 11 compliance of systems under your responsibility. You will lead cross-functional teams to define and improve the effectiveness and validity of the Biopharma GMP/GDP IT systems. You will be the key point of contact for Quality IT validation best practices. Your key interfaces will be Corporate Quality and Information Technologies (IT) in regards of Computerized System Validation (CSV). You will be the Process Owner of IT CSV documentation within the divisional Pharmaceutical Quality System (PQS).

 

Your qualification:

  • Academic degree in applied sciences (Chemistry, Biotechnology, Pharmacy)
  • Expert know-how in Computerized Systems Validation: Proven track record in qualification and validation of Electronic Systems Qualification (Validation) according to regulations (21 CRF part 11 and EU GMP Annex 11)
  • Excellent knowledge of GMP/GDP
  • Expert knowledge in validation of data lakes (complex IT networks, “big data analysis”) and cloud-based computer systems
  • Fluent in English, written and verbal. German language is a plus
  • Excellent interpersonal, collaboration and communication skills
  • Strong business mind-set with demonstrated ability of conceptual and strategic thinking

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil 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!

Curious? Apply and find more information at https://jobs.vibrantm.com

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