Description

I help CROs, biotech companies, and regulated manufacturers build and fix Quality Management Systems that stand up to MHRA, FDA, and sponsor inspections.

Most of my work involves organisations that are either:

Preparing for inspection
Scaling rapidly without a structured QMS
Struggling with CAPAs, deviations, or audit findings
Recovering from compliance gaps or failed audits

I operate as a hands-on QMS Consultant, delivering complete, inspection-ready quality systems aligned to ICH E6(R3), GCP, GMP, and ISO standards (ISO 9001, ISO 13485).

Recent work includes:

Building a full CRO QMS from near zero to inspection-ready (50+ SOPs, CAPA, audit, and governance frameworks)
Delivering 40+ audits across clinical and manufacturing environments (site, vendor, internal)
Supporting MHRA and sponsor inspections with zero critical findings
Reducing systemic quality issues by ~85% through structured CAPA and investigation frameworks
Implementing risk-based audit programmes across multi-site clinical operations (6 sites, 20+ studies)

What I deliver:

End-to-end QMS build and remediation
Inspection readiness (gap analysis, remediation, mock inspections)
SOP frameworks and document control systems
CAPA, deviation, and risk management systems
Internal and supplier audit programmes

Engagement model:

Short-term projects (2–12 weeks) for QMS build or remediation
Interim QA leadership / Head of Quality support
Ongoing retained consultancy

If you need a QMS that is practical, scalable, and inspection-ready, I can support from initial gap assessment through to full implementation and audit defence.

Industry field of expertise

Languages

English
Native or bilingual
Welsh
Native or bilingual

Workplace preferences

Can work on-site

Preston (up to 50km), Manchester (up to 50km)

AP Quality Consulting Ltd
QMS Consultant / Head of Quality (Contract)
BIOTECH
March 2024 - Today (2 years and 3 months)
Delivering end-to-end QMS build, remediation, and inspection readiness solutions across CRO, clinical, and regulated manufacturing environments.
Designed and implemented a full CRO QMS from near zero to inspection-ready status, aligned to ICH E6(R3), including governance structure, SOP hierarchy, and lifecycle controls
Authored and deployed 50+ SOPs and associated quality records (policies, work instructions, forms), covering:
Clinical trial governance
Vendor qualification and oversight
Audit management
CAPA, deviation, and change control
Document control and training compliance
Established a fully integrated CAPA and deviation management system, including:
Root cause analysis frameworks (5 Whys, Fishbone)
Effectiveness checks
Trending and signal detection across studies
Defined escalation pathways for critical/major findings
Built a SharePoint-based digital QMS, including:
Controlled document libraries with versioning and approval workflows
Training matrix with role-based assignment and compliance tracking
Audit log, CAPA tracker, deviation log, and risk register (Excel-integrated)
Delivered full inspection readiness programmes:
Conducted structured gap analyses against ICH E6(R3) and MHRA expectations
Developed remediation roadmaps with prioritised risk-based actions
Performed mock inspections simulating MHRA sponsor/site inspections
Prepared leadership teams for regulatory interviews and inspection scenarios
Led and executed internal and supplier audit programmes (GCP/GMP), including:
Risk-based audit planning across vendors and critical service providers
Audit execution, reporting, and CAPA follow-up
Identification of systemic quality risks across organisations
Supported validation and compliance alignment of clinical systems (CTMS/EDC), ensuring:
User access controls
Data integrity compliance (ALCOA principles)
Audit trail functionality
CAPA Management Inspection Readiness Quality Management System (QMS) GxP Compliance GCP Compliance
Panthera Biopartners
Site Compliance Specialist / Regional Quality Lead (GCP)
BIOTECH
July 2022 - September 2025 (3 years and 2 months)
Preston, United Kingdom
Led regional GCP quality oversight across multi-site clinical trial operations, acting as the primary QA function supporting site-level and study-level compliance.

Provided end-to-end QA oversight across 6 clinical trial sites and 20+ concurrent studies (Phase II–IV), ensuring consistent application of GCP standards

Planned and executed 25+ GCP audits, including:
Site audits (routine and for-cause)
Vendor audits (laboratories, service providers)
Internal system/process audits
Supported MHRA and sponsor inspections, including:
Audit hosting and coordination
Documentation readiness reviews (TMF, ISF, site files)
CAPA response development and submission
Led deviation and CAPA management across clinical operations:
Oversaw investigation of protocol deviations and compliance issues
Implemented structured root cause analysis and effectiveness checks
Reduced repeat deviations through systemic corrective actions
Established trending and signal detection processes:
Analysed deviations, audit findings, and CAPAs across studies
Identified systemic risks and recurring compliance issues
Reported trends to senior leadership for risk-based decision making
•Partnered closely with Clinical Operations, investigators, and study teams to:
Ensure protocol adherence
Improve site-level compliance performance
Embed quality-by-design principles within trial delivery
Acted as primary QA contact for assigned studies:
Provided ongoing oversight across study lifecycle
Supported study start-up, conduct, and close-out phases
Contributed to development and improvement of quality systems and SOPs within the organisation, strengthening overall inspection readiness Frameworks: ICH GCP (E6), EU Clinical Trials Regulation, MHRA expectations
Laleham Health and Beauty
Lead QC Analyst
PHARMACEUTICALS INDUSTRY
September 2020 - July 2022 (1 year and 10 months)
Kirkham, United Kingdom
Conducted QC testing and batch release support under GMP conditions
Investigated OOS and deviations using structured RCA methodologies
Supported CAPA implementation and audit readiness
Maintained data integrity and compliance with ISO 9001 and ISO 22716