EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). We offer configurable off-the-shelf products as well as customized and integrated solutions. EXTEDO's enabling technology, the EXTEDOsuite, is unique in all that it covers within Regulatory Affairs including: eCTD submission management, pharmacovigilance or drug safety management and product registration planning & tracking. EXTEDO serves over 700 Life Sciences customers, both large and small, in 60 countries, including the EMA and over 25 regulatory authorities worldwide. The areas of Life Sciences in which Extedo operates are: pharmaceuticals, biotech and biopharma, generics, medical devices, healthcare and the public sector. We are still growing!

For our location in Ottobrunn near Munich we are actively seeking a

 

Validation Manager (m/f/d)

Your Tasks - as important as our Software:

 
  • You will assume full product management for Validation Services’ offerings in compliance to GAMP 5 standard.
    In this role you will develop Validation Service offerings based on market trends, customer needs, and competitor landscape.
  • You will visit customers worldwide to understand customer requirements and to promote existing and new service offerings, in conjunction with the sales team. Based on the customer demands you will develop strategies for existing and new service offerings as well as the necessary tools to grow the business in close collaboration with the rest of the organization.
  • Operationally, you will coordinate internal and external validation activities and conduct functional risk assessment workshops with clients,
  • You will gain deep knowledge of the regulatory environment and EXTEDO products,
  • You will develop your professional career based on your strength!

Your Profile - as good as our Solutions:

 
  • You have a degree or diploma in a technical or computer science discipline or comparable qualification,
  • You have extended experience and expertise in the field of computer system validation,
  • You have experience in managing international projects,
  • You think and act risk-based and process-oriented,
  • You have an accurate and meticulous working method.
Support us with your GxP expertise and skill to validate business critical and highly configurable systems. You will lead validation projects in hosting and customer environments following GAMP 5 standard. In cooperation with international teams you will manage projects, consult customers and develop concepts and risk-based procedures to validate regulatory systems for our clients in the pharmaceutical industry. As part of your responsibility, you will ensure that validation activities provide required evidence in compliance to US FDA 21 CFR Part 11 and EU GMP Annex 11.