Senior Manager, Client Quality, Technical and Validation
Core
Strategic leadership for Client Quality Account Management and Validation functions, ensuring GMP compliance, regulatory submissions, and product quality for biopharma clients.
Role type
Senior Manager, Client Quality and Validation
Builds
Quality Agreements, validation programmes, regulatory submissions, and compliant product releases for biopharma partners.
Domain
Biopharmaceuticals / Quality Assurance / Regulatory Compliance
Deliverable
client delivery
Required skills
GMP compliance, validation programme management, team leadership, risk management, regulatory inspection support, change control, statistical analysis, report writing, project management
Preferred skills
Qualified Person (QP) eligibility, Lean/Six Sigma Green Belt, ILM Level 5+ management qualification
Technologies
Computer systems for complex data tasks and validation protocols
Responsibilities
Lead and develop the Quality Account Manager and Validation teams; oversee client quality requirements, NPI, and regulatory submissions; manage qualification and validation activities for processes and equipment; act as senior escalation point for complex technical and regulatory matters; review and approve client documentation and validation reports; support hosting of client and regulatory audits; drive continuous improvement in quality processes; manage staff resources and budgets; liaise with Business Development for proposals requiring QP input.
Seniority
Senior, hands-on IC with people management responsibilities