GRAIL

To ensure regulatory compliance of GRAIL’s software products and systems and act as a subject matter expert in medical device software regulations and software development methodologies. Also to lead software design control efforts, enforce GxP and CSV principles, ensure software system audit readiness and support cross functional teams.

Senior Staff Quality Engineer

Maintained the integrity of transformative non-medical software, while leading UK Software Quality activities with software design control and enforcing GCP and CSV principles for UK Software development, crucial for pioneering products like multi-cancer early detection test.

Cisiv Ltd

. Delivery of quality and validation policies, SOPs and work instructions that are compliant to FDA and MHRA regulatory expectations and in line with industry specific standards (GAMP/ISPE)
· Worked with all relevant policies and standard operating procedures that have been defined based on the requirements of: ISO/IEC 9001:2015 Quality Management Systems and ISO/IEC 27001:2017 Information Security Management Systems
· Worked with applications developed and/or supported that can potentially contain personal data that is subject to general law (UK / EU GDPR, UK DPA 2018) as well as industry specific regulations (DSP and HIPAA).
· Provide regulatory training in CSV, GAMP5 and GCP principles to ensure regulatory compliance for relevant staff

Quality Manager

British Compliance Institute

Brought in to demonstrate the company's commitment in addressing complex compliance issues promptly and effectively, mitigating regulatory risks, and safeguarding public health.
·	Provided independent and expert assessment of the company's processes, systems, and products to identify areas of non-compliance and gaps in processes and developed a comprehensive remediation plan which included corrective actions, process improvements, training programs, and documentation updates to prevent issues from occurring in the future reducing the risk of non-compliance issues or regulatory sanctions.

Senior Validation Consultant

Experienced Quality Leader with a demonstrated history of success in diverse sectors, spanning over 9 years. Known for driving operational efficiency, ensuring regulatory compliance, and enhancing product integrity, especially in underdeveloped software environments. Skilled in implementing effective quality management systems with a strong focus on continuous improvement.

Taplio

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