Quality leaders carry product quality, patient safety and reliable supply, and every site is judged on its inspection record. Quality and GMP is where Russell has worked longest, and where most of our recent work sits.
The revised EU GMP Annex 1 for sterile manufacturing requires a site-wide Contamination Control Strategy, reviewed by management, with more weight on barrier technology and filter integrity testing.1
For hiring: Sterile sites need QA and microbiology leads who can own that strategy and defend it in front of an inspector.
The first rewrite since 2011 of Annex 11 (computerised systems) and Chapter 4 (documentation), plus a new Annex 22 on artificial intelligence. The comments were still being worked through in 2026; nothing is final yet.23
For hiring: CSV and data-integrity profiles need refreshing, and people who can validate AI in a GMP setting are a new and scarce profile.
A QP is notified through Farmatec, and IGJ assesses education and experience against Article 49 of Directive 2001/83/EC. A foreign degree needs a Nuffic comparison first.4
For hiring: Not every QA manager can be named QP. The IGJ check belongs in the timeline of every QP search and interim cover.
IGJ inspects every medicines manufacturer in the Netherlands periodically and issues the GMP certificate when the site complies.5
For hiring: Inspection readiness is one of the clearest tests of a head of quality, alongside quality culture and reliable supply.
Most credible candidates are employed, regularly approached and rarely on the market for long. They move for a site they believe in, a mandate that is clear, and a quality function that has the backing of the site head.
Timing matters as much as the profile. Some strong permanent candidates hesitate to join a site with open findings until the remediation plan is credible; an interim lead can stabilise the site first, although the right permanent leader will take on a remediation when the authority and resources are clear. A validation lead who resigns over a salary gap is often cheaper to keep than to replace. Several of the stories below turned on exactly that advice.
After an audit or inspection finding: first relevant profiles within two working days, structured around the Wet DBA.
When the QP workload is a few days a month, not a full-time job.
Mid to senior searches for the specialist roles where the network matters more than the job board.
Retained search, with a written weekly status and a replacement guarantee.
Interim quality lead placed for the remediation; permanent search once the site had stabilised.
Read the full story →Head of Quality and Regulatory split into a Head of Quality now and a regulatory appointment later.
Read the full story →Brief and budget recalibrated in week one; candidate presented in person; filled in twelve weeks.
Read the full story →A counter-offer instead of a replacement search.
Read the full story →Internal promotion, with Russell recruiting the QC Manager behind her.
Read the full story →Tight market; hire came from the network, sold on knowledge of the client.
Read the full story →Every suitable specialist in range approached; the hire had not been actively looking.
Read the full story →Request out within an hour; interviews in week one.
Read the full story →Full-time search declined; a few days a month, structured around the Wet DBA.
Read the full story →Delivered in three weeks, partly from outside Europe; all started within a month.
Read the full story →A thirty-minute call with Russell, no pitch deck. You'll leave with a view on whether it's a search, an interim, or neither.