HELEN NWANDU
Blackpool
Summary
Accomplished biomedical scientist with over 10 years in quality assurance within GxP-regulated environments. Specialises in CAPA, deviation management, and QMS improvements, driving regulatory compliance and operational efficiency. Enhanced quality systems and reduced nonconformities through effective SOP governance and risk-based strategies, fostering a culture of quality across teams.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Specialist Biomedical Scientist – Quality
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool
12.2024 - Current
- Lead and execute internal audits aligned with GMP principles and ISO 15189 standards, strengthening inspection readiness and regulatory compliance across laboratory operations.
- Drove Quality Management System (QMS) improvements through compliance monitoring, quality metrics analysis, and continuous improvement initiatives that enhanced regulatory adherence.
- Direct deviation investigations, nonconformity management, CAPA implementation, effectiveness checks, and root cause analysis activities within regulated laboratory environments.
- Administered deviations and nonconformances within Ulysses incident management systems, ensuring accurate documentation and effective CAPA tracking for improved compliance insights.
- Review, approve, and maintain SOPs, controlled documentation, validation records, and quality documents in accordance with GDP and ALCOA+ principles.
- Manage QMS iPassport user access, controlled documentation workflows, and compliance records while delivering staff training on SOP governance and regulatory process adherence.
- Conduct risk assessments using DATIX and QMS iPassport systems, implementing process controls to strengthen specimen handling and operational compliance.
- Supported UKAS transition accreditation to ISO 15189:2022 through gap assessments, audit preparation, SOP harmonisation, controlled documentation review, and QMS implementation activities.
- Provided proactive quality oversight and compliance guidance to multidisciplinary teams, reinforcing quality culture and ensuring adherence to regulatory standards.
Acting Research & Development Lead – Pathology
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool
05.2025 - 11.2025
- Drive quality and compliance oversight across 20+ clinical research and laboratory programmes, ensuring inspection readiness, data integrity, and alignment with GCP and MHRA standards.
- Oversee biospecimen lifecycle management processes, ensuring traceability, documentation accuracy, and adherence to controlled sample handling procedures.
- Implemented centralised sample tracking systems and controlled documentation workflows, enhancing audit readiness and ensuring regulatory compliance.
- Developed and standardised SOPs, compliance training materials, and quality documentation, strengthening laboratory governance frameworks.
- Coordinated audit support, monitoring visits, CAPA follow-up activities, and risk mitigation initiatives, ensuring adherence to regulations in laboratory operations.
- Collaborate cross-functionally with R&D, pathology, and clinical teams to resolve quality-related issues and strengthen protocol compliance.
Program Laboratory Specialist (Quality Assurance Focus)
HJF Medical Research International – Walter Reed Program
04.2015 - 09.2022
- Directed quality oversight for deviations, CAPA implementation, change control activities, and quality improvement programmes, ensuring compliance and enhancing laboratory performance as Deputy Quality Officer.
- Directed quality oversight across high-throughput GxP-regulated laboratories processing 1,000+ samples daily from 300+ referral sites.
- Led root cause investigations and risk assessments that reduced laboratory nonconformities by 50% and strengthened operational compliance.
- Ensured adherence to SOPs, GLP, GCP, and sponsor requirements supporting internal, external, and accreditation audits.
- Supported A2LA accreditation, EQA performance, assay validation, and controlled documentation practices, contributing to regulatory compliance and operational excellence within regulated environments.
- Maintained end-to-end biospecimen traceability and coordinated international shipments with full cold-chain and documentation compliance under IATA regulations.
Education
MSc - Healthcare Management & Leadership
University of Worcester
United Kingdom01-2023
MSc - Public Health
University of South Wales
United Kingdom01-2022
BSc - Medical Laboratory Science
Madonna University
Nigeria01-2009
Skills
- GMP/GLP/GCP Compliance
- Regulatory compliance
- QMS-Ipassport, Ideagen
- Audit readiness
- CAPA & Deviation Management-Ulysses, DATIX
- Risk Assessment/Risk Management
- Root Cause Analysis
- Validation Documentation
- Document governance
- Laboratory Operations Oversight
- GDP & ALCOA
- ISO standards -ISO 9001, ISO 15189, ISO 17025, ISO 31000
- Laboratory health and safety awareness
- Sample tracking
- Training delivery
Certification
- GCP (ICH E6)
- GLP
- Laboratory IT and Clinical Informatics
- Lean Six Sigma
- Research Governance
- Total Quality Management
- Health, Safety and Environment (HSE)
- IMPs
- Bio-risk Management
- IATA Dangerous Goods Shipment (DGR)
Accomplishments
- Reduced laboratory nonconformities by 50% through implementation of CAPA, root cause investigations, risk assessments, and continuous quality improvement initiatives within GxP-regulated laboratory operations.
- Reduced analytical nonconformities by 35% through Quality Management System (QMS) optimisation, compliance monitoring, and strengthened process control measures.
- Maintained <3% sample rejection rate across high-throughput laboratory operations by enhancing specimen quality controls, traceability processes, and SOP compliance standards.
- Supported successful A2LA accreditation and UKAS ISO 15189:2022 transition activities through audit support, controlled documentation review, quality system alignment, and inspection readiness initiatives.
- Coordinated 100,000+ international biospecimen shipments with full chain-of-custody traceability, cold-chain integrity, controlled documentation, and regulatory compliance under IATA and GxP requirements.
Websites, Portfolios and Profiles
https://www.linkedin.com/in/helennwandu/
Affiliations
- HCPC Registered Biomedical Scientist
- IBMS Member
- CQI Member
- ASQ Member
- HRA Research Ethics Committee Member
- NIHR External Peer Reviewer
Timeline
Acting Research & Development Lead – Pathology
Blackpool Teaching Hospitals NHS Foundation Trust
05.2025 - 11.2025
Specialist Biomedical Scientist – Quality
Blackpool Teaching Hospitals NHS Foundation Trust
12.2024 - Current
Program Laboratory Specialist (Quality Assurance Focus)
HJF Medical Research International – Walter Reed Program
04.2015 - 09.2022
MSc - Healthcare Management & Leadership
University of Worcester
MSc - Public Health
University of South Wales
BSc - Medical Laboratory Science
Madonna University