Quality Strategy Lead Computerized Systems (all genders)

Posted 21 Nov 2018

Darmstadt, Hesse - Germany

Req Id 184691

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. 
 


The Computerized Systems Quality Strategy Lead (CSQSL) will provide Quality oversight of computerized systems and electronic data integrity through proactive coordination, quality support, coaching and consultation. The Quality Strategy Lead is also responsible for creating, maintaining and supervising a GLP, GCP and GVP compliant, efficient and global computerized system life cycle approach including the validation strategy for GxP computerized systems. The position will be responsible for creation, establishing and maintaining a GxP compliant computerized system validation approach. The Quality Strategy Lead will also be accountable for Quality Oversight and electronic data integrity during system life cycle. It provides expert support for R&D IT projects and supports Quality Assurance Audits of global and local IT systems. In addition to that the Quality Strategy Leader will also represent R&D Quality in R&D internal IT project governance meetings.

 

Who you are:

 

• University degree in scientific or quality-related subjects. Advanced degree in relevant subjects preferred.  Equivalent relevant professional experience may be considered.

• Minimum of 8 years of equivalent work experience of quality management in GxP regulated areas or ISO 9001 with a minimum of 3 years in IT validation of global computer systems

• Fluency in written and spoken English

• Broad knowledge/expertise of IT development lifecycle model and of world-wide accepted IT validation standards (GAMP or equivalent)

• Broad knowledge/expertise in continuous improvement with background in appropriate tools/procedures e.g. strong quality orientation and understanding of metrics, project management tools, Lean Six Sigma

• In depth knowledge of worldwide regulations and guidelines e.g.  21 CFR part 11, ICH, PICS, OECD

• Solid working knowledge of principles and concepts of quality risk management

• Advanced knowledge of software and hardware systems and a solid understanding of the potential use of technology solutions in a business environment including cloud computing

Demonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem-solving capabilities.

 



What we offer: With us, there are always opportunities to break new ground. 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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