Director, Quality Assurance search
GCP quality leadership: the QMS, the audit program, vendor oversight, and being ready when an agency arrives. Often urgent, and often urgent for a reason.
Clinical quality searches tend to arrive with a deadline attached: an inspection is scheduled, a finding needs closing, a partner has asked hard questions during diligence, or the person who held the whole quality system in their head has resigned.
That urgency is real and it is also the main risk in the search, because a rushed quality hire is how you get someone who can describe a QMS but has never built one.
What we actually assess
- Inspection experience, specifically. Being in the room for an FDA or EMA inspection, and what happened. Front room, back room, and how they handled a request they could not immediately satisfy.
- CAPA that actually closed. Anyone can write a CAPA. We ask for one they owned end to end and what changed as a result.
- QMS built versus QMS inherited. A Director who stood up a quality system at a growing company has a fundamentally different skill set from one who administered a mature one.
- Vendor and CRO audit judgment. Where they have pushed back on a vendor, and what it cost them internally to do it.
- The ability to be unpopular constructively. Quality leaders who are never in tension with operations are usually not doing the job. Quality leaders who are always in tension are also not doing the job.
Where these searches go wrong
Hiring GMP experience for a GCP problem
They are both quality and they are not interchangeable. A strong GMP manufacturing quality leader dropped into clinical quality has to learn the entire regulatory frame of a different function. Filters that say "quality" without saying which one produce shortlists that miss.
Hiring an auditor to build a system
Auditing and system building are different capabilities. Many candidates are excellent at one and untested at the other, and job descriptions rarely distinguish.
The urgency compresses assessment
When an inspection is eight weeks away, the temptation is to hire whoever can start Monday. This is the role where that goes worst, because inadequate quality leadership is invisible until it is very visible.
How we run it
We separate the immediate need from the permanent need, which often means placing an experienced interim to cover the inspection while running the permanent search properly. Then we map for the specific version of quality you need, GCP and clinical rather than generic, and assess against inspection and CAPA reality rather than titles.
A recent quality assurance leadership search closed in 21 days on a role that had been open for months before we were brought in. Speed came from knowing who to call, not from lowering the bar.
Questions about this search
We have an inspection in two months. Can you fill this in time?
Possibly, and the safer answer is usually to place an experienced interim for the inspection window while running the permanent search properly. Hiring a permanent quality leader under inspection pressure is how companies end up hiring again in a year.
Does GMP quality experience transfer to GCP?
Partially. The quality mindset transfers; the regulatory frame, the inspection dynamics, and the vendor landscape do not. For a clinical quality role we would want to see real GCP exposure rather than an intent to learn it.
Do you place quality roles below Director?
Yes, including QA managers, auditors, and inspection readiness specialists, on both permanent and contract terms.
Related searches
Is this the role that has not moved?
Send us the spec and the history. You will get an honest read on the pool and on what is holding it up.
Let us look at the search
Tell us the role, the level, and how long it has been open. If it is one we can fill, you will know quickly. If it is not, you will hear that too.