Kay H.

Kay H. has a diverse and extensive work experience in quality assurance and project management roles. Starting in 2003, Kay worked as an Operations Standards Manager at Roche, where they managed projects to enhance the performance of the clinical operations department. Kay also established and implemented operational standards teams for various therapeutic areas.

In 2005, Kay joined GlaxoSmithKline as the Director of Clinical Pharmacology & Discovery Medicine Business Operations. In this role, they managed change projects and led a team responsible for aligning procedures with quality requirements and early phase clinical development stakeholders' needs.

Kay continued their career at GlaxoSmithKline as a Director of Business Planning & Performance at the Centre Clinical Study Excellence. Kay managed the IT investment project portfolio for Clinical Development, ensured alignment with the business strategy, and facilitated the annual update of the CCSE business plan.

In 2011, Kay returned to Roche, initially as a Principle Team Leader and then as a Team Lead, focusing on service provider QA strategy and clinical quality risk management. Kay developed methodologies for assessing risk relative to service providers engaged in globally sponsored clinical trials and led audit strategies for GCP-related activities.

Kay then took on leadership roles at Roche as the Head of Strategic Operations in Product Development Quality Assurance, where they provided operational leadership and contributed to the development and delivery of the PDQA Risk-Based Strategy. Kay also served as the PDQA Head of CSV & Service Provider Strategy, developing and implementing risk-based strategies for regulated systems used by Pharma global functions.

In 2019, Kay worked as a Quality Assurance Manager at PDS Ltd before moving to TRI - The RBQM Company in 2020, where they held the position of Quality Assurance Manager. Currently, Kay is working as an IT QA Compliance Officer at Allergy Therapeutics since September 2022.

Throughout their career, Kay has demonstrated strong leadership skills, strategic thinking, and expertise in quality assurance and project management in the pharmaceutical industry.

Kay H. obtained a Master of Science (MSc) degree in Managing Business Information Technology from Bournemouth University. Kay attended the university from 1997 to 1999. In 2016, they pursued a Diploma in Interior Design from the National Design Academy, completing the program in 2017. Prior to their higher education, Kay H. attended Castlefield School in Dorchester from 1985 to 1989, but no specific degree or field of study information is provided for this period.