Build vs. Borrow: When an In-House QA Department Stops Making Sense
Hire the quality roles that require continuity and institutional memory: the head of quality, day-to-day QA oversight, and anyone who must hold authority permanently. Contract the roles defined by peaks and by narrow specialism: mock inspections, remediation surges, and expertise you need a few weeks a year rather than continuously.
What are you actually deciding?
Not cost per hour, which is where this conversation usually starts and why it usually reaches the wrong answer. Contract rates look expensive next to a salary and cheap next to a salary plus recruitment, benefits, management overhead and the cost of the vacancy while you search. The decision that matters is about continuity. Some quality work depends on knowing why a decision was made three years ago, on relationships with the people who run the process, and on holding authority that has to be permanently available. That work belongs in-house regardless of the rate. Other work is episodic and depends on expertise you cannot justify keeping idle.
Which roles belong in-house?
Anything requiring continuous authority or institutional memory. The head of quality, because the role has to be able to stop things and be seen to have that power permanently. Core QA oversight of routine operations, because a contractor cycling through cannot hold the thread of a deviation trend across quarters. Any role a regulator expects to be permanently available, which in the EU includes the pharmacovigilance function's continuous contactability. The test is simple: if the role's value comes from having been there for the last two years, hire it. If its value comes from having done this at forty other companies, borrow it.
Key takeaway
If the role's value comes from having been there two years, hire it. If its value comes from having done this at forty other companies, borrow it.
Which roles should you contract?
Three categories. Peaks: inspection preparation, a remediation programme after a finding, a filing surge. Hiring for a peak leaves you over-staffed afterwards, and the alternative — asking the existing team to absorb it — is how the routine work slips and creates the next finding. Narrow specialism: a Qualified Person for batch certification, Annex 1 sterility expertise, a specific therapeutic area for an audit. Deliberate outside perspective: an internal auditor who audits the colleagues they eat lunch with will find less than someone with no relationship to protect. That last one is a genuine argument for borrowing even when you could afford to build.
Frequently asked questions
Is contracting more expensive?
Per hour, usually. Per outcome, often not, once you account for recruitment lead time, the cost of a vacancy, management overhead and the risk of hiring permanently for a temporary peak. Compare total cost of the outcome, not the rate.
Can a contractor hold the head of quality role?
For a defined interim period, yes, and it is a common bridge during recruitment. As a permanent arrangement it is usually the wrong structure, because the role's authority depends on being embedded and continuously present.
How do we avoid losing knowledge when a contractor leaves?
Make documentation a deliverable rather than a courtesy. Specify in the engagement what will be written down, where it will live, and who on your side owns it afterwards. Knowledge transfer that is not contracted rarely happens.
Sources
- ICH Q10 Pharmaceutical Quality System, International Council for Harmonisation. ich.org
- EudraLex Volume 4, Chapter 2 — Personnel, European Commission. health.ec.europa.eu
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