Shaun Knights

Head Of Regulatory & Quality at Calla Lily Clinical Care

Shaun Knights has a strong background in quality assurance, regulatory compliance, and continuous improvement. Shaun is currently working as a Senior Consultant Quality Specialist at Cambridge Design Partnership. Prior to this, they held the position of Head of Quality & Regulatory at Calla Lily Clinical Care. Shaun also served as the Quality & Continuous Improvement Director at PolarSeal and as an Advisor to the Callaly Board. Shaun has extensive experience in quality management and process improvement, having worked as a Director at Refresh Business Improvement and as a Senior Quality Engineer at Philips. Earlier in their career, Shaun held senior management roles in business excellence and quality & continuous improvement at Siemens Healthcare. Shaun also worked as a Continuous Improvement Technical Fellow at Visteon. Shaun started their career as an R&D Technician at Agilent Technologies.

Shaun Knights obtained an MSc in Automotive Engineering Design Manufacture & Management from the University of Hertfordshire from 2002 to 2005. Prior to that, they attended Copleston High School from 1984 to 1989. In terms of additional certifications, they have obtained qualifications such as FDA 21 CFR part 820 Lead Auditor, ISO 13485 / ISO 9001 Lead Auditor, Certified Master Black Belt (MBB), 2016 UK Excellence Award Assessor, and Lean 6 Sigma Master Black Belt.

Location

Sudbury, United Kingdom

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Calla Lily Clinical Care

Calla Lily Clinical Care is a British medical device startup developing a leak-free, convenient and dosage-confident delivery platform for vaginally-delivered drugs. We are initially focused on delivering progesterone for miscarriage prevention and IVF, where there is an unmet need for a patient-friendlier means of drug administration during an already stressful fertility journey. Progesterone prescriptions have significantly increased following the Nov 2021 update to internationally-renowned NICE's guidance on miscarriages. Subsequent applications include treatments focused on menopause and on the vaginal microbiome. Our patented technology has received FDA clearance and was named one of TIME magazine’s Best Inventions of the Year.


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Employees

11-50

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