Josh Treacher

Manager, Quality Assurance International @Exact Sciences

Oxford, GB

Exact Sciences is a global leader in the field of genomic cancer screening and precision oncology. I lead the Quality Assurance (QA) team within the International organisation (Ex-US). My team\'s responsibilities include:• Representing Exact Sciences Corporation within the International business unit- QA support for new product introduction projects including regulatory submissions for the CE mark within the EU, RCB/PMDA approval in Japan and commercial implementation- QA support for product development of relevance to Ex-US products including design control, risk management to ISO14971, software / artificial intelligence development to IEC62304- Supporting audits by external regulators and notified bodies e.g. BSI, PMDA, Tokyo Metropolitan Authority- Ensuring compliance / conformance to IVDR, 21 CFR Part 820, Japan Ordinance 169/135, GDPR/Privacy, AI Act and ISO13485 requirements- Performing audits of critical suppliers throughout Europe- Assisting with product non-conformity investigations and post-market surveillance activity• Oversight of the QMS of the company\'s clinical laboratory based in Trier, Germany- Ensuring compliance to ISO17020/ISO15189, DAkkS and Rili-BAEK requirements- Supporting audits by safety and accreditation bodies e.g. DAkkS- Harmonisation of the QMS with other global Exact Science laboratories- Day-to-day quality assurance support e.g. change control, non-conformance, training / competence

University of Southampton

MChem, Chemistry