Consultant / Senior Consultant CSV & GxP Compliance Consultant Pharmacovigilance / Biotech / Cl[...] in London

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 have spent a decade or more in pharmaceutical IT quality, validation, or GxP compliance. You have 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. Your 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.

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.

What You’ll Actually Do:

• 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.

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.
• 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 focused more on those with a PV / Clinical make-up.

Requirements:

• 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 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:

• Rates/salary based genuinely on experience.
• 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 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.