Nicola Sutcliffe

Lead Quality Engineer @ Scapa Healthcare

About Nicola Sutcliffe

Nicola Sutcliffe is a Lead Quality Engineer at SYSTAGENIX WOUND MANAGEMENT, LIMITED, with over 20 years of experience in quality compliance and process improvement in the pharmaceutical and healthcare sectors.

Work at SYSTAGENIX WOUND MANAGEMENT, LIMITED

Nicola Sutcliffe has served as the Lead Quality Engineer at SYSTAGENIX WOUND MANAGEMENT, LIMITED since 2016. In this role, she leads quality compliance projects and drives continuous improvement activities within the organization. Her responsibilities include ensuring adherence to quality standards and regulatory requirements, contributing to the overall effectiveness of the quality management system.

Experience at Covance Laboratories

Nicola Sutcliffe worked at Covance Laboratories - BioPharmaceutical CMC Solutions from 2008 to 2013 as a Senior Compliance Officer and Process Improvement Manager. During her five years there, she focused on enhancing compliance processes and implementing improvements. She is currently employed at Covance as a Process Excellence Black Belt for Early Development, a position she has held since 2013.

Previous Role at AstraZeneca

Nicola Sutcliffe's career includes a tenure at AstraZeneca, where she held the position of Project Co-Ordinator for ten months in 2000 to 2001. She later served as a Computer Validation Officer from 2001 to 2005 for four years. Her roles involved overseeing project coordination and ensuring compliance with computer validation standards.

Education and Expertise

Nicola Sutcliffe studied Applied Biological Sciences at The Manchester Metropolitan University, where she earned a B.Sc. Her educational background supports her expertise in quality assurance processes, regulatory compliance, and conducting clinical and cosmetic trials. She possesses skills in computer validation and is experienced with systems such as SAP, Oracle, LIMS, and Minitab.

Leadership and Management Skills

In her current role, Nicola Sutcliffe deputizes for the Quality Operations Manager, demonstrating her leadership and management capabilities. She is experienced in organizing, coordinating, and participating in regulatory audits, ensuring compliance with FDA and MHRA standards. Her experience in leading quality compliance projects further emphasizes her management skills within the quality assurance domain.

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