How we work together (for organisations)

​Fractional Head of Clinical QA

For organisations that need senior Clinical QA leadership on an ongoing basis, but are not yet ready (or not structured) to hire full-time.

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I provide strategic QA oversight, advise on governance and decision-making, support your team in operating with clarity and confidence, and represent QA at the level where it needs to be present.

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This is a defined, bounded engagement — not an open-ended arrangement. We agree on scope, time commitment, and what success looks like.

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Typical duration: three to twelve months, with a clear handover.

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Interim QA Leadership

​For organisations navigating a leadership gap: whether through a departure, a restructure, or a period of transition. I step in as a steady senior presence while the right long-term solution is found.

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I do not embed to create dependency. I embed to keep things moving, protect standards, and leave the function in better shape than I found it.

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Typical duration: one to six months.

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Pre-Inspection Readiness

Regulatory inspections, whether FDA, EMA, or from local Regulatory Authorities, are moments of truth. Everything does not need to be perfect, but your organisation must be able to account for itself clearly, calmly, and credibly.

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I work with you in the period before an inspection to:

• conduct an internal gap assessment across your clinical QA processes

• review open issues, CAPAs, and deviation patterns to identify what inspectors are likely to focus on

• speak with key staff to understand how the system is actually operating — not just how it is documented

• help you see your own system as an inspector would see it

• support your team in preparing to respond with clarity and confidence​

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This is an honest, experienced assessment followed by practical guidance.

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Typical engagement: four to ten weeks, depending on scope and urgency.

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Post-Inspection Recovery

If an inspection has not gone as expected, the period that follows is critical. How you respond, not just the immediate and short term corrections to the findings, but in how you think and act, determines whether this becomes a turning point or a recurring pattern.

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I work alongside your leadership team to:

• make sense of what the findings are actually pointing to

• distinguish between procedural gaps and deeper systemic issues

• support the development of a CAPA response that is credible, proportionate, and genuinely addresses the root cause

• advise until the issues are resolved and the organisation is on stable ground

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Typically project-based, scoped to the specific inspection outcome.

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Quality Crisis Support

Some situations don't arrive with a clear label. Something isn't working: quality is inconsistent, the team is under strain, decisions impacted quality are not implemented, or a pattern of issues has emerged without an obvious explanation.

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I help organisations in this position get clarity. Through structured assessment, honest conversation, and experienced judgment, I work with you to understand what is actually happening and what needs to change — at the system level, not just the surface.

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Scoped individually, depending on the nature and complexity of the situation.

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What this service is not

I do not conduct investigator site audits, vendor audits, or TMF audits. I do not write SOPs. I do not replace your operational QA team.

I provide senior judgment, system-level oversight, and experienced leadership — the things that determine whether quality issues are resolved or simply managed.

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Who this is for

This track is designed for:

• Biotech and pharmaceutical companies in early to mid-stage development without a full-time Head of QA

• Organisations preparing for or recovering from regulatory inspection

• Companies navigating leadership transitions in their quality function

• Any organisation that needs experienced, senior Clinical QA presence — without a permanent hire

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A quick note on how I work

I arrive as one person, with 25 years of experience in clinical research and quality assurance, and I work closely with your people to understand your system and help you make it stronger.

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My value is in the quality of what I see and what I help you do with it.

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When you're ready

If any of the above describes where your organisation is right now, the right first step is a conversation.

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Not a pitch. A conversation, to understand your situation and whether this kind of engagement would genuinely serve you.