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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.

Quality and Environmental Lead Irlam, Manchester Monday to Friday £35,000 to £42,000 Bonus, Pension, Holidays and industry leading training Overview This is a brilliant opportunity to work with a unique UK manufacturer that embraces continuous innovation in both product development and business techniques. They are currently in a period of growth and looking to bring a technically minded Quality & Environmental lead to support the Manufacturing function. This is a truly exciting role to work cross functionally across a dynamic business. Role Description • Drive delivery of departmental goals, championing improvements and cross‑functional engagement., • Lead ISO 14001 ownership, embedding environmental compliance and performance across site operations., • Manage, coach and develop the QE/QEC team while ensuring strong daily quality coverage., • Maintain compliance with ISO 9001/14001, supporting audits, documentation, legislation updates and PPWR readiness., • Lead internal audits, investigations and corrective actions to strengthen quality and environmental performance., • Oversee EMS activities, including risk assessments, legal registers, sustainability actions and site‑wide environmental monitoring. Skills and Qualifications • Three ‑plus years of hands ‑on Quality and Environmental experience in manufacturing, with at least two years leading people., • Strong track record running ISO 9001/14001 systems, audits, documentation and external audit readiness., • Lead Auditor qualified (or equivalent experience) with solid RCA and CAPA capability., • Highly organised, confident communicator able to influence behaviours and deliver clear reports. In return for your commitment my client offers a stable and secure career. If you feel this is of interest, please click the link to apply If you are interested in this position please click 'apply'. Hunter Selection Limited is a recruitment consultancy with offices UK wide, specialising in permanent & contract roles within Engineering & Manufacturing, IT & Digital, Science & Technology and Service & Sales sectors. Please note as we receive a high level of applications we can only respond to applicants whose skills & qualifications are suitable for this position. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business. Job Tenure: 0 Salary: £35000 - £42000 per annum + Bonus, Pension, Training Location: Irlam, Greater Manchester

Biomedical Scientist | Pathology | Full Time | Perm | Manchester We're looking for a motivated Biomedical Scientist to join our Pathology team at Manchester Hospital. This full‑time, role offers the chance to work in a supportive, well‑equipped laboratory while playing a key part in delivering accurate and timely diagnostics for our patients. Shift patterns include: -Mon-Friday: 7-3, 10-6, 12-8 Weekends 8-4, 10-6 including On call requiredIf you're passionate about high‑quality laboratory practice and keen to contribute to a collaborative healthcare environment, we'd love to hear from you. Duties and responsibilities To assist in the organisation, management and development of services within specialty of expertise provided by the laboratory. To liaise with the Laboratory Consultant and the Laboratory Manager, to ensure the provision of the high-quality service in an efficient and cost-effective manner. Plan, analyse, assess and report pathology investigations. Analyse, interpret and report information and knowledge related to ideas and concepts. Develop and evaluate the movement of laboratory specimens, blood and tissues. Assist with research and development. Plan, monitor and quality assure the application of technology for measuring and monitoring pathology investigations. Provide and receive complex, sensitive or contentious information. Develop own knowledge and skills and that of others. Promotes best practice in health and safety and security. Assist in maintaining and developing services. Contribute to quality improvement.Who we're looking for Qualifications and Training Degree qualified, HNC Medical Laboratory Sciences or equivalent which would allow individual to be eligible for Associate Membership of the Institute of Biomedical Sciences. Biomedical Scientist with the Health & Care Professions Council. Experience Working within a performance driven culture while maintaining safe standards. Assists in meeting financial and budgetary targets. Supporting the commercial development of pathology services locally Experience in a scientific laboratory. Experience of independent sector Strategically commercial and familiarity with service developments. Experience of working in partnership with consultants and participating in helping to create innovative solution for new pathology services. Uses evidence-based practice Auditor Benefits We offer employees a competitive salary as well as a comprehensive benefits package which includes but is not limited to: • 35 days annual leave inclusive of bank holidays - Employer and employee contributory pension with flexible retirement options - Spire for you' reward platform - discount and cashback for over 1000 retailers - Free Bupa wellness screening - Private medical insurance - Life assurance - Free onsite parkingOur Values We are extremely proud of our heritage in private healthcare and of our values as an organisation: • Driving clinical excellence - Doing the right thing - Caring is our passion - Keeping it simple - Delivering on our promises - Succeeding and celebrating together - Our people are our difference; it's their dedication, warmth and pursuit of excellence that sets Spire Healthcare apart.For us, it's more than just treating patients; it's about looking after people We commit to our employees well-being through work life balance, on-going development, support and reward. Spire Healthcare is a leading independent hospital group in the United Kingdom and the largest in terms of revenue. From 39 hospitals and 8 clinics across England, Wales and Scotland, Spire Healthcare provides diagnostics, inpatient, day case and outpatient care. Spire Healthcare are proud to be an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive culture for all. Our people are our difference, it's their dedication, warmth and pursuit of excellence that sets Spire Healthcare apart

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Identify risks within the audited unit besides the audit scope performed. They now appointed Citrus Global Finance to assist them in finding talented Senior IT Auditor to join their team based in Mannheim. Communicate with other departments and with operational auditors.

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Job Title: European IT Internal Audit SeniorReporting to: European IT Supervising Internal Audit SeniorDirect Reports: NonePosition Type: Permanent, 35 hours per weekHybrid: 3 days in the office 2 from homeOverview:**WhyStanding still is not an option in the current world of

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DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. You��

Due to the international nature of my clients’ audit operations, we will be looking to find a candidate who has a solid understanding of ITGC’s, ITAC’s and IT Security and also Operational and Financial auditing activities. With the Head of IT Audit based out of Chicago and your line manager b

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As a member of our Community, you will also be invited to events, which can help your wellbeing, educate you about the market you operate in, help you connect with the business as well as other members of the Community. Ensure regulatory compliance, and mitigate risks from increasing digitisation an

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