GCP Auditor

GCP Auditor page is loaded## GCP Auditorlocations: UK – Stevenagetime type: Full timeposted on: Posted 21 Days Agojob requisition id: JR100028**Work with us** Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.**Job Description:**Job Title: GCP AuditorReports to: Director, Clinical Quality AssuranceDepartment: Quality AssuranceHours: Monday – Friday, core office hoursLocation: Stevenage (hybrid)**About Autolus**Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.**Why Autolus**Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, and pension.**Our Promise**Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.**Role Summary**To perform the role of Audit & Vendor Manager on behalf of Autolus, with primary responsibility for managing and executing a broad range of Good Clinical Practice (GCP)-focused audits, including internal audits, investigator site audits, and external vendor audits. This role plays a critical part in ensuring ongoing compliance and quality within our clinical development programs.As a key member of the Clinical Quality Assurance (CQA) team, you will lead planning, execution, and reporting of GCP audits across Autolus clinical trials, processes, and vendors. You will also oversee the qualification and ongoing management of clinical vendors, collaborating closely with contract owners throughout the vendor lifecycle. Additionally, you will support regulatory inspection readiness and inspection activities at both Autolus and investigational sites.Note: This role requires international travel of up to 30%.**Key Responsibilities*** Lead the planning, conduct, and reporting of international GCP audits, including internal, investigator site, and vendor audits.* Manage audits conducted by third-party audit vendors, ensuring consistent quality and alignment with Autolus standards.* Maintain and update the annual risk-based audit plan, with formal reviews conducted biannually.* Track and report audit metrics, including risk indicators and trends from audit findings.* Oversee the qualification, onboarding, oversight, and offboarding of clinical vendors in collaboration with contract owners.* Ensure that SOPs supporting audit and vendor management processes are optimised, current, and aligned with best practices.* Proactively identify and escalate compliance risks to CQA and R&D management.* Contribute to, or lead, process improvement initiatives within CQA.* Keep the Director of CQA regularly informed on audit progress and highlight any critical issues.* Support inspection readiness activities and regulatory inspections (e.g. mock inspections, preparation of documentation, front/back room support).* Ensure compliance with Autolus quality standards, policies, and procedures.* Perform other duties as reasonably assigned by your line manager.**Demonstrated skills and competencies****E- Essential****P- Preferred****Qualifications & Experience*** Degree (graduate or postgraduate) in a scientific discipline (e.g. life sciences, pharmacy, nursing), or equivalent relevant experience in clinical research or clinical QA. **E*** Significant experience conducting international GCP audits or serving as an inspector within a regulatory authority. **E*** Strong background in vendor qualification, oversight, and relationship management. **P*** A recognised Clinical Research or Clinical Audit qualification is desirable. **P*** Experience with GCLP and/or GVP audits is advantageous but not essential. **P*** Proficiency in data mining and analytics would be beneficial. **E****Skills, Knowledge & Competencies*** Excellent verbal and written communication skills. **E*** Strong influencing, negotiation, and conflict resolution abilities. **E*** Deep understanding of GCP and applicable international regulatory guidelines (e.g. ICH, FDA, EMA, HTA). **E*** Working knowledge of other GxPs (e.g. GMP, GVP) is a plus. **E*** Analytical thinker with a strong risk-based mindset. **E*** Ability to engage and communicate effectively across all levels of the organisation. **E*** Collaborative and flexible approach to working with internal teams and external partners (CROs, vendors, consultants). **E*** Self-motivated and highly organised, able to prioritise effectively and work under pressure. **E*** Decisive, with the ability to manage ambiguity and resolve issues pragmatically in a fast-paced biotech environment. **E**Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard.Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.### Get In TouchIntroduce yourself to our recruiters and we\’ll get in touch if there\’s a role that seems like a good match. #J-18808-Ljbffr