Consultant profile
Nigel Cryer
Senior GMP Consultant | Quality, Compliance & Inspection Readiness
Nigel brings 40 years of hands-on and strategic experience across API, pharmaceutical, biotech and vaccine manufacturing. He has led quality and regulatory functions at Sanofi, NextPharma, Crucell (Janssen), Merck & Co., Roche and DHL Life Sciences, and now advises top-10 pharma and biotech companies through his own consultancy, Bluciela-Lifesciences. His approach is pragmatic and criticality-focused: keep systems simple, effective and right first time.
What Nigel brings to your organisation
- Inspection readiness and recovery
- preparation for and support during FDA, EMA/ANSM, MHRA, Swissmedic and Health Canada inspections, including Pre-Approval Inspections, warning letter and consent decree avoidance. Track record of 12 FDA and 13 Swissmedic inspections.
- Sterility assurance
- contamination control strategy, aseptic processing, environmental monitoring, HEPA management and particulate reduction.
- Data integrity
- initial assessments, lifecycle plans, data governance, training and culture change.
- Validation and qualification
- risk-based lifecycle validation for processes, equipment, cleaning, utilities, water systems and computerised systems.
- Quality systems
- QMS design and remediation, including deviations, OOS, CAPA, change control, complaints, supplier and audit management.
- Audits
- criticality-based supplier, CMO/CDMO, automation and GDP audits.
- Projects and organisations
- new facility and construction projects, product launches and transfers, organisational assessments and quality culture programmes.
- Critical issue management
- quality escalations, multi-country recalls and regulator liaison.
Nigel is a Fellow of the Royal Society of Chemistry and a regular speaker and trainer for ISPE, PDA and APIC-CEFIC. He is based in Normandy and works in English and French.
Work with Nigel
Describe your project or inspection and we will come back in English or French.
Contact PCS France