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Location: Newark - Onsite Are you a detail-driven Quality Engineer who loves improving processes, strengthening systems and making a genuine impact on product excellence? If you thrive in a fast-paced technical environment and want a desk-based role where your engineering mind really gets to shine, this could be your next move. We're supporting a leading precision engineering business that supplies into highly regulated sectors and they're looking to add a passionate Quality Engineer to their growing team. This is your chance to join a company that values continuous improvement, invests in it's people and champions a culture of accountability, clarity and excellence. What you’ll be doing In this varied role, you’ll be a key guardian of the company’s Quality Management System - ensuring compliance, enhancing processes, and supporting a strong right-first-time culture. Your day-to-day will include: Quality Management System • Maintaining and improving the QMS to AS9100, ISO 13485, ISO 9001 and FDA standards, • Reviewing and developing quality procedures, work instructions, and documentation, • Supporting internal, customer and regulatory audits, • Providing engineering support for manufacturing and inspection teams, • Leading First Article Inspections (AS9102), • Creating and reviewing control plans, inspection plans and acceptance criteria, • Supporting IQ/OQ/PQ validation activity, • Assuring validated state of manufacturing processes, equipment and software, • Leading investigations using 8D, Fishbone and 5 Why methods, • Implementing, verifying and closing CAPAs, • Supporting supplier qualification and audits, • Managing incoming quality concerns, • Driving Lean, Six Sigma and operational excellence initiatives What you’ll bring Essential: • Previous experience in a Quality Engineering role, • Strong understanding of inspection & test equipment, • Excellent communication and documentation skills, • Degree in Engineering, Quality or related field, • Six Sigma Green/Black Belt, • Auditor certification, • Experience in aerospace or medical devices, • Knowledge of AS9100, ISO 13485 & ISO 9001, • Experience with ERP (EFACS), SPC tools (MeasurLink), and project management Why apply? You’ll join a supportive, forward-thinking engineering organisation where quality is truly valued - and where your ideas, expertise, and continuous-improvement mindset will make a visible impact.Other roles you might have applied for:Quality Assurance Engineer, Quality Manager, Quality Assurance Administrator, Q&A Engineer

Computer System Validation & GxP Compliance Consultant/Senior Consultant Pharmaceutical/Biotech — Remote (UK) - Multiple Positions Consultant and Senior Consultant Roles available. Package: Excellent Hourly Rates (£75-£100 p/hr) or Salary (£60k- £90k) offered in-line with Experience 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. 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. 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 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.

AssureBio is supporting a globally established pharmaceutical organisation in the appointment of a GVP QA Manager to strengthen its R&D Quality Assurance function. This is a high-impact role focused on pharmacovigilance quality oversight, vendor governance and regulatory inspection readiness within a global environment. You will operate as a key Quality Subject Matter Expert, ensuring robust compliance, patient safety and proactive regulatory readiness across pharmacovigilance and wider GxP activities. The position offers strong cross-functional exposure, working closely with senior stakeholders, global partners and regulatory bodies. Key Responsibilities GVP & R&D Quality Oversight • Provide leadership across pharmacovigilance QA activities within R&D and Scientific functions, • Act as SME for GVP/GxP compliance and provide expert regulatory interpretation, • Maintain oversight of Pharmacovigilance System Master File (PSMF) integrity, • Support quality due diligence for new product opportunities Audit & Vendor Management • Develop and maintain the R&D audit schedule, • Lead internal, vendor and third-party audits (acting as Lead or Co-Auditor), • Oversee quality performance of PV vendors and service providers, • Ensure effective audit closure and CAPA tracking Inspection Readiness & Compliance • Support regulatory inspection preparation and hosting (MHRA, EMA, FDA and global authorities), • Lead CAPA management arising from inspections and audits, • Provide risk-based QA advice to cross-functional teams, • Review and approve deviations, change controls and quality events Quality Systems & Continuous Improvement • Generate and present R&D quality metrics to senior stakeholders, • Deliver GxP training and guidance across the organisation, • Maintain awareness of evolving regulatory expectations and ensure business readiness, • Support continuous improvement of quality systems and processes This role is central to ensuring high standards of pharmacovigilance compliance, vendor oversight and inspection readiness across a complex global environment. Experience & Qualifications Essential • Scientific degree (Pharmacy, Chemistry, Biology, Engineering or related) or equivalent experience, • Significant QA experience within pharmaceutical and/or medical device environments, • Strong expertise in Good Pharmacovigilance Practice (GVP), • Proven experience supporting regulatory inspections and PV teams, • Experience in auditing, CAPA management and quality systems oversight, • Ability to operate autonomously and make risk-based quality decisions Desirable • Certification in auditing or Quality Systems Management, • Working knowledge of Good Clinical Practice (GCP), • Experience managing PV vendors and service providers, • Strong stakeholder engagement and influencing skills Candidates must demonstrate the ability to operate independently, provide strategic quality input and maintain strong regulatory compliance across global PV operations.

Are you an experienced engineering professional ready to lead technical teams and drive operational excellence? Do you want to join a global leader in calibration services with a strong focus on sustainability and career progression? If so, we have an exciting opportunity for you as a Technical Lead Engineer at Trescal. Before applying for this role, please read the following information about this opportunity found below. About the Role Job Purpose Responsible for conducting specialist and complex calibration and repair operations developing and following procedures and ensuring compliance with Client contractual and KPI obligations. Key Responsibilities Calibration of measuring instrumentation to National UKAS standards. Identify and develop productivity improvement opportunities and support operational efficiency projects. Maintain calibration instrumentation, equipment, and facilities to required standards. Analyse complex technical problems and deliver solutions where precedent may not exist. Propose & drive continuous improvement to processes Conduct all duties in accordance with Company Health and Safety Procedures, Policies and Safe System of Work. Complete all assigned Quality and Continuous Improvement activities in accordance with Company Procedures. Maintain and produce accurate Calibration Records enabling the production of Calibration Certificates. Produce, review, develop and audit automated and manual Calibration Procedures in accordance with Company requirements and from Clients and Auditor recommendations. Provide technical support to colleagues on request in line with capability. Lead, co-ordinate and facilitate Technicians and Engineers (not supervise) work; assist in their formal orientation and training. Maintenance of Calibration Certification and files. Participate in Trescal Interlaboratory measurement audits. Participate in external/internal audits as required by the Trescal Quality Manager within the customer/Trescal facility. Occasionally you may be required to perform other tasks which are not included in the above description but are within the capabilities of the individual and where necessary training will be given. Benefits • Competitive salary, • Continuous development and training plan, • 25 days holiday and the option to buy/sell days, • Flexible working options, • Access to the Trescal PerksHub, • Employee well-being programme, • Medical Health Cash Plan, • Pension and Life Assurance Scheme, • Cycle to work scheme Formal qualification in a relevant engineering discipline or extensive demonstrable experience in and understanding calibration, both practical and theory. Strong knowledge of BS EN ISO/IEC 17025. Strong understanding of Windows-based and Laboratory automation software. xrnqpay Advanced and specialized expertise with considerable work experience Good dexterity in order to undertake manual adjustments on high accuracy instrumentation. Key Performance Indicators Sales, EBITDA Turnaround time, on time delivery

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law. MAIN PURPOSE OF JOB To work with the finance/accounting team on key specialised Group activities focusing on external reporting, technical accounting and SOX internal controls. A key position within the Finance organisation ensuring external deliverables are met for SEC reporting and UK Statutory accounting compliance, within a rapidly expanding and evolving business for a US-listed organisation. KEY RESPONSIBILITIES Experience & Knowledge Essential • Strong technical accounting experience in both IFRS and US GAAP, • Experience of undertaking reporting to the SEC, including writing SEC-compliant disclosures, • Experience of working in or closely with international companies, ideally with a US presence, • Proven ability to drive change in a fast-moving environment, • Evidence of credibility with management and external stakeholders, • Experience of performing or testing internal controls in a SOX environment, • ACA/ACCA/CIMA/CPA accounting qualification essential Desirable • Experience with Pharma/Biotech, • Experience of UK statutory filings, • Experience in public accounting KEY BEHAVIOURAL ATTRIBUTES Education & qualifications Professional accounting qualification