Monheim am Rhein - Sr. Clinical Quality Assurance Associate (f/m)

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- To partner with Global Projects and Devleopment, Global Medical Affairs, Global Drug Safety and Pharmacovigilance and GMP Quality Operations in driving quality in the clinical activities across the UCB sites. - To design and implement a robust clinical quality risk management program that profiles and mitigates risks associated with patient safety, data integrity and regulatory compliance. - To provide direct compliance and investigative support to UCB activities which are regulated by GCPs. - This position will support operations related to global development of new drugs and / or new indications using GXP principles. Qualifikationen Minimum of 3-5 years of work experience in Clinical QA auditing of clinical programs or 3-5 years experience with direct clinical development.  Good working knowledge of GXP principles relative to the development of pharmaceutical products.   Specific Skills: - In-depth knowledge of worldwide regulations pertaining to GCPs for pharmaceutical products. - Knowledge and experience in auditing electronic systems and 21 CFR Part 11 computer system validation. - Excellent writing, verbal, listening skills.  Presentation skills necessary. - Possess management and organization skills in an environment of rapidly changing priorities. - Commitment to qua ...

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