Principal Quality Lead
Core
Design and implement risk-based Quality strategies, lead complex audits, and manage regulatory inspections for pharmaceutical entities and service providers.
Role type
Principal Quality Lead (Pharmaceutical/Regulatory)
Builds
Quality assurance frameworks, audit methodologies, and compliance evidence for Health Authorities.
Domain
Pharmaceutical industry, Clinical Trials, Pharmacovigilance, Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP, GVP, CSV, risk-based auditing, issue management, stakeholder communication, regulatory inspection management, SOP development, mentorship
Preferred skills
Data analytics, data visualization, change management, global matrix organization experience
Technologies
Data analytics tools, visualization tools
Responsibilities
Design and implement Quality Strategies; Issue Management for Service Providers and Suppliers; Define Audits and Methodology; Perform and Lead Audits; Quality Conclusion Drawing; Stakeholder Communication; Health Authority Inspections; PDQ Goals and Initiatives; Expertise and Mentorship
Seniority
Principal, hands-on IC with strategic leadership
