QA Director, biologics CDMO
CDMO · Randstad, on-site · Permanent
Site-level quality leadership at a growing contract manufacturer: own the quality system, hold the line with clients and inspectors, and build a QA team that keeps pace with a site adding capacity. A brief we are asked to fill regularly, in this shape.
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
A QA Director search at a biologics CDMO is one of the engagements in our recent work, and the brief keeps arriving in the same shape. This is that shape, with the identifying details removed, so that quality leaders who could step into it know what the role actually asks for before a real one lands. Register with the form on this page and you hear when it does.
The role
You own quality at a single manufacturing site: the quality management system, QA operations, QC oversight and the site’s standing with its clients’ quality organisations and with the inspectorate. You report to the site head or general manager, sit on the site leadership team, and carry the quality voice in every decision about capacity, clients and investment.
What must be true a year after you start that is not true today: audit findings from clients are closing on time and not recurring; the deviation and CAPA backlog is under control and trending down; the QA team is staffed for the site’s actual volume rather than last year’s; and the site head can put you in front of a new client’s head of quality without briefing you first.
The environment
A biologics or sterile CDMO in the Randstad, typically with a few hundred people on site, adding capacity or new capabilities on top of an established business: a new modality such as cell or gene therapy, high-potency containment, or an aseptic fill-finish line. Several clients, each with its own quality agreement and its own audit schedule. An inspection history that is respectable but has left a list of commitments. A QA team of somewhere between ten and thirty, often with a strong operational core and a thin layer of people who can lead.
The site head who briefs this role tends to say a version of the same thing: the last QA Director was excellent at compliance and never left the office. They want someone who is equally sound on the regulations and who also walks the floor, talks to clients as a peer, and can say no in a way the commercial team accepts.
What we look for
- Ten or more years in GMP quality, most of it in biologics, sterile or ATMP manufacturing, with at least one role leading a QA function of meaningful size.
- Direct experience of a CDMO or a multi-client site: quality agreements, client audits, the tension between a client’s timeline and your release decision.
- Hands-on with IGJ or other EU competent-authority inspections, and FDA inspections where relevant, ideally having led a site through one and its follow-up.
- Fluent English; Dutch is a strong advantage for the inspectorate relationship and the shop floor, not a requirement.
- Someone who has built or rebuilt a QA team, not only inherited one.
QP eligibility is welcome and sometimes required, depending on how the site has organised batch certification.
Practical
Permanent, on-site, with the flexibility that a leadership role at a manufacturing site allows. Package in line with a site leadership team position at a mid-sized CDMO; the real numbers are part of the first conversation, not the listing. For you, the process is always the same: a real conversation before any introduction, and nothing shared without your say-so.