Internal auditor jobs in AbingdonCreate job alerts

About the Role: I'm partnered with an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. A commercial-stage business committed to improving transplantation outcomes throughout the world, their first product has been used to support more than 5,000 transplant operations globally, and they are growing fast. They are now looking for a highly motivated and detail-oriented Quality Auditor to join their dynamic Quality team. In this pivotal role, you will lead and execute internal audits across their sites and conduct supplier audits to ensure products are safe and effective, verify full alignment with their Quality Management System, regulatory requirements, and industry best practices. This is a business that takes quality seriously because what they make genuinely matters — and they're looking for someone who understands that distinction. If you think beyond checklists, see audits as an opportunity to strengthen a business rather than just verify it, and want to work somewhere where the work has real meaning, this is worth a conversation. Key Responsibilities • Plan and conduct internal and supplier product and manufacturing audits in accordance with quality agreements and regulatory requirements including ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR, • Identify areas for improvement within the QMS and supplier systems, and support the implementation and verification of corrective actions, • Develop and deliver audit reports, communicate findings to management, and monitor the effectiveness of corrective measures, • Support the development and implementation of action plans based on audit outcomes, • Support supplier qualification activities through audits for approval and periodic re-evaluation, ensuring adherence to quality agreement requirements and managing updates or revisions as necessary, • Partner with Procurement and Product Quality teams, providing audit data to support supplier qualification and re-evaluation processes, and collaborating to monitor supplier performance, • Foster strong working relationships with suppliers to drive continuous improvement and compliance, • Participate in and support external inspections and audits including BSI Notified Body and FDA, • Stay current with changes in applicable quality regulations and standards, providing training and guidance to internal teams as needed Skills & Experience • Audit Experience: Minimum 3 years in ISO 13485 QA-focused roles, including at least 1 year of hands-on practical auditing. Lead Auditor certification in ISO 13485, MDR or MDSAP desirable, • Interpersonal Skills: The ideal candidate is able to build rapport with auditees, anticipate reactions, and deal professionally with all situations. This role requires emotional intelligence and the ability to communicate the value of audits, making stakeholders feel at ease while encouraging open dialogue and genuine collaboration., • Critical Thinking & Continuous Improvement Mindset: We're looking for someone who thinks beyond checklists, someone who can look at processes end-to-end, ask the right questions, and spot practical ways to improve efficiency, compliance and overall performance, benefiting both quality and business outcomes., • Analytical Abilities: Strong attention to detail and demonstrable experience with process improvement, • Technical Proficiency: Proficient in Microsoft Office applications including Excel, PowerPoint, Visio and Word. Knowledge of MasterControl and Power BI is advantageous., • Organisational Skills: Organised, detail-oriented, and able to multitask and prioritise responsibilities in a fast-paced environment Qualifications • University or college degree, preferably in life sciences, quality, or regulatory affairs, or an equivalent combination of education and experience, • Minimum 3 years of experience in medical device quality system auditing or equivalent Location: Oxford-based, 3 days on-site with 2 days work from home per week. Ideally within a 50-mile / 1-hour commute of Oxford. Travel: 10–15% across Europe and the US for supplier audits

Job purpose Reporting to the Director, Quality Operations EU/RoW (Molecular Imaging Platform), the Senior Manager Quality Operations, EU/RoW will be responsible for managing the quality operations of Blue Earth Diagnostics’ EU/RoW based third-party Contract Manufacturing Organisation (CMO) network and oversight of the supply chain. This includes ensuring that medicinal products supplied by the company are manufactured, released and distributed in compliance with UK, EU and RoW applicable laws and regulations. The position requires operational oversight and cross-functional collaboration to maintain a robust and consistent supply of quality products in accordance with regulatory requirements. Main Responsibilities, Activities, Duties and Tasks • Serve as the primary quality point of contact for EU/ RoW -based Contract Manufacturing Organizations (CMOs), overseeing manufacturing performance, resolution of quality-related issues and managing quality relationships with CMOs., • Qualify new CMOs and perform periodic requalification according to Blue Earth Diagnostics (BED) procedures., • Maintain and manage the risk-based audit schedule., • Ensure appropriate documentation and maintenance of quality oversight records, including routine monitoring and follow-up actions., • Manage and oversee CMO investigation reports, including analytical Out of Specifications, to ensure technical accuracy, regulatory compliance, and effective root cause analysis., • Lead routine quality meetings with CMOs to manage performance, deviations, complaints, changes, improvements, and escalations., • Gather data and perform trending and analysis of CMO performance and quality to proactively identify risks and drive continuous performance improvement., • Conduct scheduled on-site CMO audits in accordance with the annual audit schedule and manage approved contract auditors as applicable., • Work in accordance with quality risk management principles., • Support the continuous enhancement of the Blue Earth Diagnostics Quality Management System (QMS), including SOP revisions, process optimization, and alignment with global standards., • Contribute to the development and presentation of Quality Assurance metrics and reports for Quality Management Review (QMR)., • Monitor regulatory changes related to EU PET and pharmaceutical manufacturing, quality, and distribution; evaluate impact and initiate updates to internal processes as needed., • Assess, document, and track complaints, deviations, and CAPAs to ensure timely, thorough, and effective resolution and preventive action., • Operate in compliance with the Blue Earth Diagnostics Quality Management System and regulatory requirements., • Train, coach and support Blue Earth Diagnostics personnel in quality and compliance requirements. Education A degree in a science related discipline is desirable. Professional Experience, Knowledge & Technical Skills • Comprehensive knowledge of EU GMP regulatory legislation and ICH guidelines obtained within sterile and/or radiopharmaceutical Manufacturing operations. Knowledge of US CFR is desirable., • Experience with hosting or acting as SME for Regulatory Authority GxP inspection process., • Trained GxP auditor or having sufficient knowledge and experience to perform GxP audits and to assess, select and manage/oversee contract GxP auditors and maintain the audit schedule., • Experience with Positron Emission Tomography (PET) or radiopharmaceutical products is strongly preferred., • Demonstrated experience overseeing and managing third-party Contract Manufacturing Organizations (CMOs) or other suppliers, including performance monitoring and issue resolution., • Comprehensive understanding of Quality Management System (QMS) principles, quality oversight, deviation management, CAPA, change control, and quality risk management practices., • Proven ability to collect, consolidate, analyze, and interpret operational and quality performance data to generate meaningful information, • Excellent investigation, problem solving, and report writing skills., • Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills with ability to work effectively with others at all levels of the organization., • Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities., • Highly skilled or advanced knowledge of Microsoft 365 package (i.e., Word, Excel, PowerPoint) and experience with Power BI is desired but not essential.

Audit & Accounts Semi Senior - OxfordWe are currently in the process of recruiting for a national, highly-regarded professional services firm in Oxford. Our client has 2 or 3 available roles at this level, Semi Senior or Senior/ Part Qualified Accountant/ Auditor. Due to the amount of recent audit wins, and internal progression our client are looking to expand their Audit team in Oxford. This is a great opportunity to work as part of a successful team where you will assist with the completion of audit assignments, as well as having responsibility for the preparation of year-end accounts and the associated tax work for limited companies, sole traders, and partnerships.The ideal candidate may be AAT Qualified, or be currently studying towards their ACA / ACCA qualification. Some Audit and Accounts exposure is required. This is an excellent opportunity for the successful individual to join a leading regional firm of accountants where there will be genuine scope for career development and progression.The local Oxford office is commutable from areas such as Basingstoke, Reading, Newbury, Abingdon, Swindon, Hungerford, Andover etc.Skills:AAT Qualified or ACA / ACCA Part QualifiedSome experience of assisting on audit assignments is essentialFor further information on this role please contact Rich Clark at Clark Wood - / Mobile: #CWRC

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

Audit & Accounts Semi Senior - OxfordWe are currently in the process of recruiting for a national, highly-regarded professional services firm in Oxford. Our client has 2 or 3 available roles at this level, Semi Senior or Senior/ Part Qualified Accountant/ Auditor. Due to the amount of recent audit wins, and internal progression our client are looking to expand their Audit team in Oxford. This is a great opportunity to work as part of a successful team where you will assist with the completion of audit assignments, as well as having responsibility for the preparation of year-end accounts and the associated tax work for limited companies, sole traders, and partnerships.The ideal candidate may be AAT Qualified, or be currently studying towards their ACA / ACCA qualification. Some Audit and Accounts exposure is required. This is an excellent opportunity for the successful individual to join a leading regional firm of accountants where there will be genuine scope for career development and progression.The local Oxford office is commutable from areas such as Basingstoke, Reading, Newbury, Abingdon, Swindon, Hungerford, Andover etc.Skills:AAT Qualified or ACA / ACCA Part QualifiedSome experience of assisting on audit assignments is essentialFor further information on this role please contact Rich Clark at Clark Wood - / Mobile: #CWRC...

A global medical device company in Oxford is seeking a Quality Auditor to lead internal and supplier audits, ensuring compliance with quality standards. The ideal candidate has at least 3 years of experience in quality auditing, possesses strong analytical and interpersonal skills, and is detail-ori

The Internal Audit Manager will play a pivotal role in overseeing and improving internal audit processes within this company. Based on the outskirts of Oxford, this position requires a strong background in accounting and audit, coupled with a focus on compliance and risk management. Client Details This role is with a well-established organisation on the outskirts of Oxford, they are known for their commitment to innovation and operational excellence in their field. Description Lead the planning, delivery and reporting of internal audits, consulting engagements and internal controls testing across the global business. Ensure full end‑to‑end audit delivery in line with professional standards, presenting findings and agreeing remediation plans with management. Manage co‑sourced and outsourced audit partners. Identify risks, recommend control enhancements, and help improve processes across the organisation. Conduct follow‑up reviews to ensure agreed actions are implemented and controls operate effectively. Build strong working relationships with senior management, control owners and key stakeholders. Support Finance team to strengthen control environments and embed best practice. Prepare regular reports for senior leadership and governance committees. Lead or support key Internal Audit projects and contribute to the development of the annual audit plan. Assist with risk management activities and contribute to board‑level reporting. Collaborate with external auditors and finance teams to help resolve audit findings. Profile A successful Internal Audit Manager should be a confident auditor with strong communication skills, the ability to challenge constructively, and the credibility to influence senior stakeholders. Experience and skills required: ACA, ACCA, CA or CIMA qualified (or equivalent). Solid post‑qualified experience in internal or external audit. Strong written and verbal communication skills with excellent attention to detail. Good knowledge of IFRS, corporate governance principles, and global regulatory requirements. Strong analytical and problem‑solving skills. Ability to identify control weaknesses and recommend practical improvements. Clear communicator able to present complex information effectively. Proactive, flexible and able to manage multiple priorities. Strong organisational and time‑management skills. Ability to lead or coordinate other audit resources when required. Understanding of performance management principles. Familiarity with international accounting standards and willingness to learn new frameworks. Job Offer Competitive salary Hybrid working model for a better work-life balance. Opportunity to work in the thriving global business. Permanent role based in Oxford with room for professional growth.If you are ready to take the next step in your career, apply now for this Internal Audit Manager role and contribute to the success of a leading organisation

Job Title: ISO 9001 Lead Auditor Location: Abingdon, Oxfordshire (UK) Employment Type: Full-time / Permanent About the Role We are seeking an experienced ISO 9001 Lead Auditor to join our team in Abingdon. This role is ideal for a quality professional with a strong background in highly regulated industries such as Nuclear, Oil & Gas, or Pharmaceuticals. You will play a key role in maintaining and improving our Quality Management System (QMS), ensuring compliance with ISO 9001 standards and industry-specific regulatory requirements. Key Responsibilities • Plan, lead, and conduct internal and supplier audits in accordance with ISO 9001 standards, • Manage audit schedules, reports, and follow-up corrective actions, • Ensure compliance with regulatory and customer requirements within highly regulated environments, • Support external audits conducted by certification bodies and clients, • Identify risks, non-conformities, and opportunities for continuous improvement, • Provide guidance and training to internal teams on quality standards and audit readiness, • Maintain and improve QMS documentation and processes Requirements • Certified ISO 9001 Lead Auditor (IRCA or equivalent), • Proven experience auditing within highly regulated industries (Nuclear, Oil & Gas, or Pharmaceuticals), • Strong knowledge of ISO 9001 standards and quality management systems, • Experience with regulatory frameworks and compliance requirements, • Excellent analytical, reporting, and communication skills, • Ability to work independently and manage multiple audit projects Desirable Skills • Experience with integrated management systems (e.g., ISO 14001, ISO 45001), • Familiarity with risk management methodologies, • Previous experience working with certification bodies or in supplier auditing What We Offer • Competitive salary and benefits package, • Opportunity to work in a high-impact, compliance-driven environment, • Professional development and training opportunities, • Collaborative and supportive team culture How to Apply