Jobs, fresher vacancy - Associate Director, GCP Quality • Oxfordshire

Company: Exscientia

Oxfordshire

About UsExscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our pipeline demonstrates our ability to rapidly translate scientific concepts into precision-designed therapeutic candidates, with more than 15 projects underway. By designing better drugs, faster, we believe the best ideas of science can rapidly become the best medicines for patients.Our Quality vision is to build a quality mindset and embed Quality by Design principles across the enterprise to enable work to be done in the right way. Quality is for everyone!Our Quality mission is to design & develop a single, fit for purpose Quality Management System (QMS) across GxP regulated areas. In addition, Quality being a trusted partner for stakeholders, with a patient & compliance focus within R&D Oncology.The RoleWe are seeking an Associate Director, GCP Quality to contribute to our company mission to develop better medicines, faster, together with our Quality mission & vision summarised above. In this role you will lead the GCP Quality support for our interventional clinical trials, serve as a GCP Quality expert to the business, and establish strong relationships with the Development & Precision Medicine functions.Key responsibilities include: Providing GCP expert advice & guidance to project/study teams Escalation of compliance risks/issues to line management Quality review of GCP essential records Actively contribute to the Quality mission to design & develop a single, fit for purpose QMS Conduct GCP process, vendor, and investigator site audits. Support GxP Quality needs in Development & Precision functions, e.g. GVP, GLP, GDP/GMP & CSV Please note this is a UK hybrid role and occasional travel is required to our Oxford, UK offices (approximately once a week) and Vienna, Austria offices (approximately every quarter), and for conducting global audits (approximately a week every quarter) with flexibility to work from home the remaining time. We are a flexible working organisation and we’re willing to consider other options which would provide similar contact time with the team.You will have the opportunity to: Provide day to day GCP compliance support to the study teams and project deliverables, in your role as Quality Lead for interventional clinical trials Monitor risks and deviations/issues in Clinical Development & escalate to line management promptly. Lead investigations into significant quality issues and potential serious breaches of GCP Conduct quality reviews of GCP essential records as required, e.g. Investigator Brochures, Protocols, ICF/PIS, key study manuals/plans (such as lab, monitoring, communication, pharmacy, data management, and statistical), clinical study report Plan, prepare, conduct, report and follow up to closure on GCP related audits Drive Quality by Design principles and Critical to Quality factors within Clinical Development Active & collaborative member of the Quality team based in the UK & Austria, supporting other Quality responsibilities as required, e.g. QMS enhancements, Veeva Quality/QMS/training system maintenance, non-interventional clinical trials, clinical sample management, non-clinical/GLP studies. Requirements Strong GCP Quality experience in biotech/pharma which spans clinical trial phases I to III Expert in GCP global regulations and guidance (e.g. ICH E6, ICH E8, EU CTR, FDA CFRs) and current GCP industry best practices. Knowledge and experience of other GxP regulations & guidance would be benefical, e.g. GVP, GLP OECD, GMP/GDP PICS, & CSV Demonstrates auditing experience across different types of GCP audits (e.g. CRO, phase I, investigator sites, essential records, process/system audits). Auditing, conduct/exposure in GVP, GLP (e.g. labs/CROs), CSV, and GMP/GDP would be beneficial Experience of participating in regulatory agency inspections, e.g. MHRA, FDA, EMA) and presenting quality metrics/analytics Introduce efficiencies to QMS (i.e. Policies, SOPs, Working Instructions) in line with Quality mission to develop a single, fit for purpose QMS across GxP regulated areas Bachelor degree in life sciences or healthcare related area. Essential skills: Excellent interpersonal and verbal/written communication skills Highly collaborative team player who listens, encourages, contributes, challenges and improves performance/deliverables Takes responsibility for delivering Quality & Development projects & initiatives through cross-functional influence Ability to think ‘outside the box’ to identify risks/challenges and deliver creative solutions Global and strategic mindset Generally needs no or minimal instructions on day to day work. Benefits Join our inclusive, collaborative and intellectually stimulating organisation with strong company values. As a learning organisation, we provide access to learning and development opportunities and will place you at the forefront of your career growth at Exscientia. We employ brilliant people so we pay highly competitive salaries. Additionally, all our employees are eligible for a company-wide annual bonus and receive both a new joiner and annual share award. Enjoy our generous holiday allowance and flexible working approach to find a healthy work-life balance that works for you. Create amazing memories or progress your personal and professional development with our four-week paid sabbatical after four years of service. We’re leading the way in progressive leave, offering enhanced policies such as generous parental leave, surrogacy, menopause, and family emergency leave so you feel supported no matter the life event. Additionally, we support childcare costs for children aged 0-5 through our affordable childcare scheme. Take advantage of two generous salary exchange schemes to claim discounts on a brand new electric vehicle and cycling equipment worth up to £3,500. As a healthcare company, we understand the importance of health and wellbeing so we provide comprehensive private health insurance, dental and vision benefits for you and your family. We also provide plenty of access to mental health support including therapy and counselling sessions plus an employee assistance program for help with lifestyle issues such as bereavement, family problems or money management. To help safeguard the future for you and your loved ones, we also offer pension and life cover. Help yourself to free drinks and snacks in our fully stocked kitchens. Join your colleagues in one of our many breakout areas and get to know the people you are working with. Some of the best ideas start with a coffee break! Feel inspired in our high spec labs where you will use state-of-the-art equipment and instrumentation that enable you to do your best work. We’ll even support your home office environment with an allowance for furniture and equipment to make your space as comfortable and productive as possible. Learn more about why our team enjoy working at Exscientia here