Global Clinical Quality Consulting, led with human values and grounded in 25 years of experience
I work with R&D organisations and Quality Assurance leaders who are ready to move from checkbox compliance to ICH E6(R3)-ready quality systems. I offer fractional or interim Clinical QA leadership, strategic QA consulting or support (teaching and advisory) for your people.
Is This You?
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You are leading an R&D organisation through a period of change (a restructure, a growth phase, an inspection or a cultural reset). You need experienced, senior QA leadership on a flexible or temporary basis.
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You are an R&D or Quality Assurance leader carrying the weight of a system that is reactive and overly complicated. You want a team who builds quality in proactively instead of putting out fires. You know culture will not change with more SOPs, but you are not sure where to begin.
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You are a Quality Assurance professional who is technically strong, but the role feels heavy. You want to make an impact without burning out, fighting resistance, or being seen as "the difficult QA person". You sense there is a better, more human way of doing this work, and you want guidance for that next step.
If any of this feels familiar, you are in the right place!
How do I help?
For Organisations
Fractional and interim Clinical QA leadership · ICH E6(R3) readiness · pre-inspection readiness · post-inspection recovery · quality crisis support · quality culture advisory
​For QA professionals and Teams
Advisory coaching · teaching · judgment · influence · boundaries · confidence · quality leadership
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Mallorie Dellac
Founder and Principal Consultant
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I bring 25 years of experience across Clinical Operations and Clinical Quality Assurance in global pharmaceutical and biotech environments.
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Good Clinical Practice expert.
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I have led R&D QA functions, navigated regulatory inspections, supported organisations through crisis and transition, and helped teams understand why quality problems persist even when the right processes appear to be in place.
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PROSCI-certified change practitioner and deep knowledge of behaviour styles and human dynamics. ​​
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