About Us
Exscientia 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 Role
We 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 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.
* 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
* Work together to make a positive contribution to patients by revolutionising the pharmaceutical industry through AI-driven discovery
* Opportunity to join an inclusive, collaborative and intellectually stimulating culture
* We will work with you to provide a highly competitive compensation as we continue to grow and thrive
* Our team’s health and well-being is important to us we offer a generous holiday allowance, provide flexible working and remote working to encourage all of our team to manage their own work, time and life along with wellbeing and mindfulness support
* When you are in the office, you will have access to a kitchen stocked with an endless supply of food for all employees. Along with access plenty of break out areas so you can get to know the people you are working with. Some of the best ideas start with a coffee break!
* Hear from our team why they enjoy working here.
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