Jan 2022 – Jul 2023 · 1 yr 6 mos · London, England, United Kingdom · Hybrid

• Delivery of independent quality oversight and management to GSK R&D; acting as the single point of accountability for one or more clinical development projects/programs.
• Delivery of an effective independent audit program that provides assurance that clinical trial activities governed by GCP and related regulations undertaken by and/or on behalf of GSK are compliant with relevant international regulatory agency regulations / guidelines, GSK policies / procedures, and are conducted in accordance with accepted principles for clinical trial research.
• Implement and manage the QA audit program for one or more clinical development projects/programs; risk prioritisation, scheduling, and tracking of QA audits. Root cause analysis and support CAPA development
• Implement and manage Quality Assurance Plans for all programs where audit activities are performed.
• Clinical QA Subject Matter Expert for Risk Based Quality Management
• Generate compliance statements for the Clinical study report
• Provide support for the coordination and management of Regulatory Inspection activities for applicable clinical programs . Serve as the main point of contact for inspection for national and local inspections (FDA, EMA, MHRA, etc.). Identification and mitigation of known quality issues and potential GCP compliance risks. Provide support in the root cause analysis activities for any inspection findings identified and support the business in development of responses
• Manage investigations of significant quality issues, root cause analysis activities and ensure subsequent corrective and preventative actions.
• Provide proactive and regular communication of trends, risk identification, analysis and performance metrics from QA audit and all investigation and inspection activities
• Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility.

Jul 2019 – Jan 2022 · 2 yrs 6 mos · London, United Kingdom

• Fulfilment of QA function responsibilities including:
• Upkeep and maintenance of Quality Management System
• Developing and delivering annual internal audit program
• Facilitating external audits and inspections from other entities and regulators
• Vendor audit assessment and oversight
• Analysis laboratory assessment and oversight
• Chair of trials unit's main oversight committee "Quality Management Group"
• Provision of training to all trials unit staff members
• Representation of the trials unit at internal and external networking and training events.

Mar 2017 – Jul 2019 · 2 yrs 4 mos · Paddington, London

• Role Responsibilities:
• Monitoring
• Chasing annual reports (APRs, DSURs)
• Monitoring risk assessment
• SAE Recording, SuSAR reporting and follow-up
• Sponsor TMF maintenance
• Data query resolution
• Overseeing regulatory compliance of Clinical trials from set-up to close out and result submission
• General sponsor oversight and support for research staff on regulatory and compliance issues
• Portfolio size 30-40 studies
• Extra-curricular Work
• Preparation for an MHRA Inspection (2017)
• Audit program development
• Audit program management
• Audit Working Practice document
• Provided QA and audit training to team members internally
• Audit SOP re-write
• JRCO SOP update coordination
• Wrote Monitoring Plan template
• CTIMP and non-CTIMP GCP audits
• System and process Audits

Jun 2015 – Mar 2017 · 1 yr 9 mos

Sep 2014 – May 2015 · 8 mos

Jul 2013 – Jul 2014 · 1 yr · Park Royal, London

May 2012 – Jul 2013 · 1 yr 2 mos · Malvern