Quality Manager
Core
Ensure quality and compliance across the pharmaceutical product lifecycle from development to commercial supply, overseeing external manufacturing partners and regulatory inspections.
Role type
Manager, Quality Assurance (Pharmaceuticals)
Builds
Investigational Medicinal Products (IMPs) and finished medicines
Domain
Pharmaceuticals / Oncology / Rare metabolic / Immunological / Neurological genetic conditions
Required skills
Quality Management System (QMS) implementation, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP), regulatory compliance (FDA, MHRA, ICH), risk assessment, SOP management, budget management, line management
Preferred skills
Strategic project contribution, cross-functional collaboration, data analysis, stakeholder engagement, training and development
Technologies
QMS platforms, regulatory databases, document management systems
Responsibilities
Implement and maintain QMS for regulatory compliance, monitor compliance with GCP/GMP/GDP, prepare for regulatory inspections, assess and mitigate product development risks, maintain quality documents and records, lead quality improvement initiatives, prepare quality metrics reports, support document reviews and QP certification, represent department on cross-functional teams, perform line management duties
Seniority
Manager, hands-on leadership with team management