Consultant / Senior Consultant CSV & GxP Compliance Consultant Pharmacovigilance / Biotech / Clinical
13 days ago
Newcastle upon Tyne
Computer System Validation & GxP Compliance Consultant/Senior Consultant Pharmaceutical/Biotech — Remote (UK) - Multiple Positions Consultant and Senior Consultant Roles available - with an emphasis on Pharmacovigilance and Clinical knowledge Package: Excellent Hourly Rates (£60-£100 p/hr) offered in-line with Experience - potential of Salaried position in the future. The Role in 20 Seconds You've spent a decade or more in pharmaceutical IT quality, validation, or GxP compliance. You've probably held titles like Validation Manager, QA Lead, CSV Lead, or IT Quality Manager — in a pharma sponsor, a biotech, a CRO, or a specialist consultancy. You know how to walk into a mid-size biotech on a Monday morning, pick up a statement of work, and get on with it. You're clinical or PV background means you can talk their language straight away. Our client is a specialist GxP and CSV consultancy that runs entirely on senior people. No juniors. No box-ticking. Their clients want experience and guidance, and you will be the face of the company. 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 CSV services to a client base predominantly in the USA, EU and UK. Their clients range from pre-revenue biotechs building their first quality management system to more mature pharma companies requiring specialist expertise for regulatory remediation, system validation, and audit programmes. They are mostly small to mid-sized clients with exciting product portfolios, generally in the "30–200 employee" range. These are 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. The quality of the work product is the commercial proposition, which means the people doing it have to be good. There's no layer of management between you and the client, and no junior to pass the awkward bits to. Some people find that energising. Those are the people we're looking for. The team is small, friendly, and above all, hardworking. They all share the same work ethic, and they are enjoying rapid growth - hence the reason for hiring. What You'll Actually Do The bread and butter: • Lead validation projects end-to-end — or execute defined work packages within them, depending on where you sit, • Plan and conduct GxP vendor audits of technology providers, from agenda to audit report to corrective action closure, • Author and renovate SOP suites, data integrity policies, change control frameworks, and vendor qualification programmes, • Deliver gap analyses and inspection readiness support that actually prepares people, rather than producing a report that sits in a drawer, • Act as the primary client contact on engagements — chairing meetings, managing stakeholder relationships, and presenting findings to senior quality and IT leadership The less obvious bits that matter as much: • Having the confidence to push back on a client when something is wrong — and the judgment to know when to pick that battle, • Translating complex regulatory requirements into proportionate, practical actions without gold-plating and without cutting corners, • Keeping an engagement on track and within budget whilst also managing the client expectations Who We're Looking For You'll be a natural fit if: • You've come up through pharmaceutical quality, validation, or IT compliance — in a sponsor, a biotech, a CRO, or a consultancy — and you've genuinely owned deliverables, not just contributed to them, • You're the person colleagues come to when there's a regulatory 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, • At the senior end — you've been the responsible professional when a regulator walked in, and you know exactly what that feels like, • This is NOT a role for manufacturing or LIMS specialists - this is focussed more on those with a PV / Clinical make-up Essential: • 10+ years in pharmaceutical quality, validation, or GxP compliance in a regulated environment, • Hands-on experience with computer system validation or quality assurance — in a pharma, biotech, or CRO setting specifically, • Proven ability to write inspection-ready documentation: validation plans, risk assessments, qualification protocols (IQ/OQ/PQ), and audit reports., • High degree of working familiarity with GAMP 5 concepts (software categories, V-model, risk-based testing) and key regulations such as ICH E6(R3), EU Annex 11, 21 CFR Part 11, and the FDA Computer Software Assurance (CSA) Guidance, February 2026., • 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 involving computerised systems, • Familiarity with eQMS implementation, data migration validation, or AI/ML in a GxP context, • RQA, ISPE, or DIA involvement, • ISO 27001 awareness or Lead Auditor certification. What's Actually In It For You The practical stuff: • Rates/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 The things that don't show up in a rate card: • Clients who are building something — clinical-stage biotechs constructing their quality infrastructure from scratch as they advance through trials, not large pharma running the same validation cycle they've run for twenty years, • Direct relationships with QA Directors, heads of IT, COOs, and occasionally CEOs — because with staff rosters of 30–200 people, that's who you're talking to, • 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 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. 📧 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 not sure 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. All applications are treated confidentially. Guess what... We're not only interested in the conventional CV. Spent fifteen years in-house at a pharma and want to move to consultancy? Coming from a CRO and want to work across a broader client base? Built your validation knowledge in a regulatory technology company rather than a sponsor? Get in touch. If the experience is real and the documentation quality is there, the background matters less than you might think.
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