Sebastian Liebau
R & d Global Quality Risk Management, Business Process Owner @Grünenthal Group
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WORK HISTORY
R & d Global Quality Risk Management, Business Process Owner @Grünenthal Group
Aachen, DE
Contributing to strategic decision-making and direction-setting as one of four senior team members within Global QA supporting clinical development • Developed and implemented cross-functional processes for proportional RbQM of CtQ factors • Supporting prospective identification, evaluation, proportionate control and periodic review of risks to CtQ factors across the trial portfolio• Collaborating with trial teams and strategic leads to drive cross-functional alignment and coordinated risk signal management across the portfolio• Providing quality leadership and coaching to cross-functional trial teams throughout the trial lifecycle, ensuring compliance and continuous inspection readiness • Analysing trial data to identify meaningful trends, trigger process improvements and facilitate knowledge sharing across trials• Representing Global QA on cross-functional projects aimed at process improvement and quality integration• Leading maintenance and continuous improvement of clinical RbQM processes• Providing leadership for preparation, management and follow-up of GCP inspection activities
EDUCATION
Bonn-Rhein-Sieg University of Applied Sciences
Bachelor's Degree, Applied Biology
University of Aberdeen
Bachelor's Degree, Genetics (Immunology)
University of Oxford
D.Phil. (Ph.D.), Clinical Medicine
University of Aberdeen
Master's Degree, Molecular & Cellular Immunology
ABOUT SEBASTIAN LIEBAU
Senior clinical quality professional with experience spanning regulatory authority and industry, including 4 years as a GCP inspector on behalf of the EMA. Proven expertise in inspection readiness, GCP compliance and RbQM, gained through leadership roles in both regulatory agencies and the pharmaceutical industry. Experienced people leader with a track record of influencing at all organisational levels and driving regulatory alignment and supporting global clinical trial operations through strategic quality initiatives. Committed to building inspection-ready, risk-proportionate quality cultures that enable effective and compliant global clinical development.
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