Qualified Persons in the UK: The Pillars of Pharmaceutical Trust and Progress
By Andrew Davis, Founder of Allerton Bishop
In a tightly regulated industry like pharmaceutical manufacturing, trust is engineered—not assumed. At the core of this trust stands the Qualified Person (QP), a role that is both legally mandated and ethically indispensable. From first-in-human trials to commercial product launches, the QP is the final authority standing between the manufacturing line and the patient.
As someone who recruits and consults for QPs across the UK and Europe, I’ve come to appreciate how pivotal this role is—and how often it's underestimated. Nowhere is this clearer than in the contrast between commercial QPs and those supporting Investigational Medicinal Products (IMPs).
Both groups operate under the overarching requirements of EU GMP and Annex 16. Yet the daily realities of their work diverge sharply.
Commercial QPs face increasing pressure to ensure every batch of a licensed medicinal product is manufactured and released in strict compliance with a Marketing Authorisation. Consistency, documentation, and robust supply chain oversight are their core concerns.
By contrast, IMP QPs operate in a fluid environment marked by protocol changes, evolving specifications, and incomplete stability data. Their challenge is to certify investigational batches for clinical use, often under uncertainty—and with patients' lives potentially at stake.
Annex 16 acknowledges this, stating its principles apply to IMPs “subject to any difference in the legal provisions and more specific guidance.” In practice, this puts the IMP QP at the junction of pragmatism and regulation.
I recently worked with a business where the Managing Director was visibly frustrated. He was recruiting for the same Qualified Person role—for the fourth time in five years. During our briefing, he summed up the challenge with refreshing honesty: “Just find me someone who can communicate and understands people. We can train the rest.”
It was a clear signal that technical capability alone is no longer enough. The decision wasn’t about commercial vs. clinical focus or experience with specific dosage forms—those were secondary. In this case, it was interpersonal qualities that became the defining factor for the hire.
This challenge becomes even more pronounced when hiring at the Quality Director level. Is holding QP status essential? Beyond the structural considerations of departmental oversight, should the qualification itself define the UK’s top quality leaders?
There’s ample evidence to suggest otherwise. Many highly accomplished Quality Directors have built exceptional careers without being QPs. That said, QP status remains a strong preference—and in many of the senior mandates we manage at Allerton Bishop, it's still seen as a key differentiator.
Modern pharmaceutical supply chains are complex, global, and frequently outsourced. QPs must understand and oversee every critical element—particularly when responsibilities are divided across multiple QPs. This is even more pronounced in clinical supply chains and CDMO outsourcing, where regulatory nuance and interdependency are the norm.
In recent years, interim and contract QP services have helped companies bridge gaps created by the shortage of permanent QPs. However, with reduced investment and fewer opportunities in the sector, the trend is reversing. Many professionals once attracted to contract roles by the significant day rates are now returning to salaried positions—and in many cases, aren’t being considered for roles when seasoned veterans are readily available.
That said, demand remains high for specialist, high-performing contract QPs—especially for complex or high-risk programmes. But the broader trend is clear: employers are refocusing on internal capability building and succession planning at both trainee and qualified levels.
The QP pathway is no easy road. Years of cross-functional GMP experience are required, covering a wide range of dosage forms and manufacturing practices. Yet many candidates falter at the final stage. I’ve spoken to numerous trainee QPs who fall short not for lack of intelligence, but because their training lacks depth, breadth, or contextual application.
As the industry evolves, so do its expectations. We’re entering a market that demands quality professionals who bring not only technical rigour, but business fluency and communication skills. Which begs the question: what’s next for hiring QPs?
The upper quartile of permanent QPs—those with leadership skills, operational breadth, and emotional intelligence—will remain in high demand. But hiring practices may need to evolve. Could we start valuing character and adaptability as much as dosage form expertise? Will leadership and people management become the new 'must-have' requirement at Head-of-level?
With next-generation therapies pushing into new territory, there simply aren’t enough QPs with exact-match experience. But COVID taught us that flexible working can expand access to exceptional talent. Employers willing to explore these models—rather than sticking rigidly to outdated hiring templates—are gaining an edge.
Big pharma can still afford to be selective. As one Talent Acquisition lead put it to me: “It’s an employer’s market—if one candidate walks, the next one’s in the queue.” That luxury isn’t shared by smaller firms.
Many of my clients are small or scaling businesses. For them, recruitment is personal. The best pharma professionals save lives—but how many employers enable their people to achieve both professional success and personal fulfilment? That’s where smart hiring strategies start to make a difference. And for many emerging pharma companies, the answer has to be yes.
These aren’t theoretical ideas. They’re real, practical factors that influence the success of hiring QPs in today’s market.
If you need insight into how to position your company, assess the talent landscape, or build a shortlist of high-impact QP candidates, I’d be happy to help.
Let’s talk.
📧 andrew.davis@allertonbishop.co.uk
📞 +44 (0)7958 109399
🌐 www.allertonbishop.co.uk
