Commercial Quality Lead & QP UK
Core
Act as the Qualified Person (QP) and Responsible Person backup for the UK market, ensuring batch certification of medicinal products and compliance with UK MIA, EU GMP, and local regulations.
Role type
Senior Qualified Person (QP) / Regulatory Compliance Lead
Builds
Certified medicinal product batches and compliant supply chain operations for the UK market
Domain
Pharmaceuticals / Regulatory Compliance
Required skills
UK QP registration, UK Responsible Person registration, MHRA eligibility, regulatory license maintenance, quality system management, supplier qualification, change control, audit management, CAPA, risk-based decision-making
Preferred skills
EMEA languages, matrix organization strategic quality management, complex virtual environment work
Technologies
GMP, EU GMP Annex 16, UK MIA, WDA, QSMR
Responsibilities
Batch certification of medicinal products, maintain local Quality system, oversee supply chain and storage, manage quality issues and complaints, prepare QP declarations, host MHRA inspections, manage Nonconformances and CAPA processes
Seniority
Senior, hands-on IC
