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Consultant - GCP, Systems Validation, Quality & Compliance
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Computer System Validation & GCP Compliance Consultant
Company: Pharmaceutical/Biotech Quality and Regulatory Consultancy
Location: Remote (UK) - Multiple Positions
Package: Excellent hourly rates offered in line with experience, with the potential of a salaried position in the future.
The Role in 20 Seconds
You've spent several years working in and around clinical trial systems - EDC, IRT, CTMS, eTMF, ePRO, safety databases - either as a validation specialist, a quality lead, or the person a clinical operations team calls when a system needs to be inspection-ready. You know GCP well enough to spot the difference between a genuine data integrity risk and a paperwork exercise. You know how to walk into a clinical-stage biotech on a Monday morning, pick up a work package, and get on with it.
Our client is a specialist GxP consultancy with a strong clinical-systems bias, built entirely on senior people. No juniors. No box-ticking. Their clients want experience and judgement, and you will be a face of the company on every engagement.
If that sounds like the kind of place you'd actually want to work, keep reading.
The Company
A lean, specialist consultancy delivering GxP compliance and computer system validation services to a client base predominantly in the USA, EU and UK. The bulk of the work sits in the GCP space - clinical trial systems, clinical data quality, and inspection readiness for sponsors and CROs - though the team also picks up broader GxP work (GMP, GDP, GLP-adjacent systems) where a client needs it.
Most clients sit in the 30-200 employee range - organisations sophisticated enough to know exactly what they need, but lean enough that they don't have the internal QA resource to do it themselves. That's the gap this consultancy fills, and it's why the work is genuinely interesting rather than purely procedural.
The model is deliberately small. Only experienced consultants are deployed. There's no layer of management between you and the client, and no junior to pass the awkward bits to. The team is small, friendly, and hardworking, and they are growing quickly - hence the reason for hiring.
What You'll Actually Do
The bread and butter:
- Execute defined work packages within validation projects for clinical trial systems (EDC, IRT, CTMS, eTMF, ePRO, safety databases), and increasingly lead smaller engagements end-to-end as you build a track record with the client base
- Plan and conduct GCP audits of clinical technology vendors, from agenda to audit report to corrective action closure
- Author and renovate SOPs, data integrity policies, and change control frameworks specific to clinical systems
- Support gap analyses and inspection readiness work ahead of MHRA, FDA, or EMA GCP inspections - work that actually prepares people, rather than a report that sits in a drawer
- Pick up broader GxP work as it comes in - vendor qualification, general quality documentation, or CSV outside the clinical space - for consultants who want the variety
- Act as a client contact on engagements - attending and sometimes chairing meetings, and presenting findings to clinical operations, quality, and IT stakeholders
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The less obvious bits that matter as much:
- Having the confidence to flag to a client when something is wrong on a trial-critical system - and the judgement to know when to escalate versus handle it yourself
- Translating GCP requirements into proportionate, practical actions without gold-plating and without cutting corners
- Keeping your piece of an engagement on track and within budget whilst managing client expectations
Who We're Looking For
You'll be a natural fit if:
- You've come up through clinical trial systems, clinical data management, or GCP-focused quality/validation roles - in a sponsor, a biotech, a CRO, or a consultancy - and you've genuinely owned deliverables, not just contributed to them
- You're someone colleagues already come to when there's a GCP systems question that actually matters, rather than one that can be answered by reading the SOP
- You ask smart questions early rather than making assumptions, and your documentation doesn't come back needing heavy rework
- You're comfortable working independently in a remote model with real deadlines and defined accountability
- You'd be interested in picking up wider GxP work alongside your GCP core, rather than staying in a single lane
Essential:
- 12+ years working with clinical trial systems or GCP-focused quality/validation in a regulated environment
- Hands-on experience validating or auditing at least one of: EDC, IRT, CTMS, eTMF, ePRO, or clinical safety database platforms
- Ability to write inspection-ready documentation: validation plans, risk assessments, qualification protocols (IQ/OQ/PQ), and audit reports
- Working familiarity with GAMP 5 concepts (software categories, V-model, risk-based testing) and key regulations including ICH E6(R3), EU Annex 11, and 21 CFR Part 11
- Right to work in the UK without sponsorship
Nice to have:
- Previous experience in a client-facing consultancy role as opposed to purely in-house
- Inspection experience with FDA, MHRA, or EMA specifically involving GCP systems
- Broader GxP exposure - GMP, GDP, or quality systems outside clinical trials - for consultants who want to flex across service lines
- Familiarity with eQMS implementation, data migration validation, or AI/ML in a GCP context
- RQA, ISPE, or DIA involvement
- ISO 27001 awareness or Lead Auditor certification
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What's Actually In It For You
The practical stuff:
- Rates and salary based genuinely on experience - we won't be trying to lowball you at interview
- Remote working as the default - occasional client site visits, planned in advance
- Contract or permanent - both considered depending on what works for you
- Fractional engagements across multiple clients, usually 1-2 month assignments, with the option of a salaried role for the right person as the business grows
The things that don't show up in a rate card:
- Clients who are building something - clinical-stage biotechs constructing their trial infrastructure from scratch as they advance through phases, not large pharma running the same cycle they've run for twenty years
- Direct relationships with clinical ops leads, QA managers, and IT managers - because with staff rosters of 30-200 people, you're rarely more than one step from the decision-maker
- A client list where your name is on the work, not buried four layers down in a consulting pyramid
- No internal politics to navigate - small team, clear accountabilities
- The satisfaction of handing over something that will genuinely hold up under a GCP inspection
The Honest Bit
This is not a nine-to-five with a clear desk at five. Client deadlines are real, inspection windows don't move, and occasionally a deliverable needs to be right by Friday regardless of when it landed in your inbox. Remote working in a fractional/contract model requires genuine self-management - there's no office to walk into and no one tracking your hours, so the only thing that matters is whether the work is good and the client is happy.
If you've spent your career in large pharma with a lot of internal support around you, the step to a lean consultancy model can be bigger than it looks. If you've done it before, or if the idea of that autonomy is what's been missing from your current role, you'll probably love it.
If you're more experienced than this ad suggests - closer to 20 years experience, with a track record of leading GCP or wider GxP engagements end-to-end - get in touch anyway. There are Senior and Principal Consultant conversations to be had as well, and it's a five-minute chat to work out where you'd actually sit.
Apply via the link, or message Andy Clarke directly if you want to talk it through first - especially if you're weighing up the contract versus permanent question, or whether your specific background is the right fit.
Andy has been in and around regulated life sciences for over two decades. You'll get a straight answer to a straight question, not a sales pitch.
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