BenevolentAI, founded in 2013, creates and applies AI technologies to transform the way medicines are discovered and developed. BenevolentAI seeks to improve patient’s lives by applying technology designed to generate better data decision making and in doing so lower drug development costs, decrease failure rates and increase the speed at which medicines are generated. The company has developed the Benevolent Platform™ - a discovery platform used by BenevolentAI scientists to find new ways to treat disease and personalise drugs to patients.
BenevolentAI is HQ’d in London with a research facility in Cambridge (UK) and further offices in New York and Antwerp. BenevolentAI has active R&D drug programmes from discovery to Phase II in disease areas such as ALS, Parkinson’s, Ulcerative Colitis and Sarcopenia.
BenevolentAI is seeking to recruit an experienced Clinical Quality Assurance Manager (for 6 months) to their clinical development group to support an on-going Phase 2 clinical programme. The Clinical QA manager is responsible for quality oversight of clinical activities and provision of support to the clinical development team ensuring applicable procedures are implemented and maintained in accordance with regulatory requirements.
Support the development and maintenance of the Quality Management System; including the preparation and revision of SOPs.
Act as the GCP QA expert for the company
Oversee the conduct and reporting of GCP audits both internal system/process audits and external audits of CROs and vendors, investigator sites, etc. This will also include the assessment, selection and management of appropriate contract auditors.
Maintain all GCP audit records.
Track audit, inspection and self-reported CAPAs and their implementation to completion, including evaluation of effectiveness checks.
Lead the preparation, conduct and follow-up for GCP Regulatory Authority Inspections and ensure compliance with required standards (i.e. EMA, FDA, ICH-GCP etc.).
Provide compliance support and guidance as the GCP quality representative on clinical projects
Responsible for the management of the quarterly QMS oversight meeting
We’re looking for someone with...
BSc in life sciences, medical or related field
Science degree in a relevant scientific discipline
Approximately 6 years’ clinical development experience preferably with at least three years’ experience of pharmaceutical or speciality pharmaceutical/biotech company
At least 4 years’ experience in GCP QA or similar compliance role including knowledge of CAPAs, change control and SOP deviations
Trained GCP auditor or having sufficient knowledge and experience to assess, select and manage/oversee contract GCP auditors and maintain the audit schedule
Comprehensive knowledge of ICH GCP, and good knowledge of EU and US FDA regulatory standards
Previous experience preparing and revising GCP SOPs
Experience with Regulatory Authority GCP inspection process
Demonstrable experience managing teams working remotely
Strong negotiation and influencing skills, being open-minded and willing to accept new ways of moving projects forward; and
An ability to solve problems independently and with others together with a flexible and can-do attitude to work.
Who are we?
We have assembled a diverse, exceptionally talented and spirited team to tackle the most pressing and challenging problems at the intersection of artificial intelligence and drug discovery. We bring our ideas and passion for new technology and medicine discover to life by questioning traditional scientific dogmas.
Our core values reflect who we are and how we work and they are so important to achieve our mission: Bring better medicine to patients faster.
Put patients first | Drive to delivery | Break boundaries | Own the solution.
Please be advised that we will hold and process your Personal Data for continuous recruitment purposes (this is irrespective of your success in this application or not) in line with vital regulatory requirements. Under GDPR/DPA2018, you have the right to be informed, access, restrict, correct or ask us to delete your Personal Data. More details available on our Privacy Notice (https://benevolent.ai/privacy/).