For this job, we need your vision and insight. We need strategies to develop global validation concepts and you will help us by asking questions like: Why do we need to approach it like this? Is it a cloud system? Is it locally installed? Is it running on a platform? This strategy is vital for us to develop a risk-based global validation concept and make life cycle documentation available.
Challenging? Definitely. Exciting? More than most jobs, we think.
Tasks & Responsibilities In your new role, you must take into account business needs as well as regulatory requirements and standards to define the strategy and documentation for validation concepts. You will decide which strategy meets the specifications. In doing so, you can count on the support of our internal Quality department. You will support systems in the area of the Clinical Data Management. Most of them on site, others in different time zones – and you will be at the center of the action, keeping things running. You will continuously communicate and negotiate on how a deliverable is to be implemented and show others how to get it right, spearheading and coordinating the entire process. By time, you will get a feeling for the support people need to achieve your common goal. If you're well versed in presenting and defending validation concepts to compliance offices and authorities as part of regular audits or inspections, then this is the right job for you. You will consult colleagues from different operational units on validation topics for specific project(s)/program(s)/system(s). You will support the collaboration within the community of validation managers. Requirements Bachelor's or master's degree with a major focus on IT, engineering, sciences, pharmaceuticals, or biotechnology (or an equivalent field). Several years' experience in complex project implementation using computer validation regulations and methods (e.g. SOPs and Corporate Procedures, Good Clinical Practice (GCP), FDA Guidelines, Code of Federal Regulations (CFR), particularly 21 CFR Part 11) and experience of data integrity. Knowledge in analysis and user requirement engineering methods. Love working in a team and bringing together people from different technical and cultural backgrounds. Strong communication skills including demonstrated willingness to create and maintain business relations and working with business partners, vendors, system leads, compliance functions. Experienced in agile working methods? Great! And if not, we'll teach you how it's done. Excellent English skills; in your department, everything is done in English.
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