Interim Head of Quality, inspection remediation
Pharma · Netherlands, on-site · 4 to 5 days a week · 6 to 9 months
Take over a site's quality function after an inspection has gone badly, stabilise it, close the commitments to the inspectorate on time, and hand over to a permanent successor. The most time-critical brief we receive, and the one we are most often asked to fill within days.
Representative brief. This is the shape of a mandate we are regularly asked to fill, written from recent engagements with the identifying details removed. It is not a live vacancy.
Why this brief is here
When an inspection produces critical or major findings, the call to Axeleon comes within days of the inspection, and the client needs the first relevant profiles within two working days. The remediation engagements on our interim specialists page started that way. This brief describes the role those calls ask for, so that interim quality leaders who could take it on are already known to us when the next one comes in. Register with the form on this page.
The assignment
You step into the site’s quality leadership role, often because the incumbent has left or has been asked to step aside, and you own the response to the inspectorate. That means a credible remediation plan with dates the site can actually meet, a CAPA programme that closes root causes rather than symptoms, a deviation backlog brought under control, and a quality team that is functioning by the time you leave.
The outcome the client is buying: the follow-up inspection passes, the commitments are met on schedule, the certificate or licence is not at risk, and a permanent head of quality has been hired and handed a working system rather than a crisis.
The environment
A pharmaceutical or biologics manufacturing site in the Netherlands, a few weeks after an inspection with findings that the board is now paying attention to. Morale in the quality team is low, the relationship with production is strained, and several people are waiting to see who is in charge. The site head is often competent and shaken, and needs a quality leader who can tell them the truth about how bad it is and what it will take.
You report to the site head or the managing director, with a direct line to the QP and, often, to a group quality function abroad that wants weekly updates.
What we look for
- A senior GMP quality professional, typically fifteen or more years, who has led a quality function through a remediation before and can describe exactly what they did in the first thirty days.
- Direct experience with IGJ or other EU competent-authority inspections, and FDA inspections where relevant, including writing and defending responses to findings.
- Fluent in the practical work: deviations, CAPA, change control, data integrity, batch record review, supplier qualification. You will be in the detail, not above it.
- Dutch is a real advantage for this brief, because the inspectorate correspondence and much of the shop floor are Dutch. Fluent English is essential.
- The temperament to be firm with production and honest with the board, and to leave when the job is done.
Practical
Four to five days a week on site for six to nine months, with a defined handover to a permanent successor as part of the assignment; Axeleon can run that permanent search in parallel. Contracted between your company and Axeleon with the Wet DBA requirements built in. Hourly rate depends on seniority and the site’s situation and is agreed before any introduction.