Associate Director, Quality Auditor, GVP
Core
Lead independent global pharmacovigilance audits and drive quality compliance strategies across R&D to ensure adherence to international regulations and GSK standards.
Role type
Senior IC quality auditor (pharmacovigilance)
Builds
Independent quality assurance programs and regulatory inspection readiness
Domain
Biopharmaceuticals / Pharmacovigilance / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance regulations, Quality audit planning, CAPA strategy, Root cause analysis, Global matrix collaboration, Regulatory inspection readiness
Preferred skills
GxP disciplines, Risk-based quality management, AI/ML for quality oversight, Third-party auditing, Professional auditing certification
Technologies
AI/ML solutions, Data analytics tools
Responsibilities
Lead risk-based pharmacovigilance audits across processes and third parties; Develop and execute audit strategies aligned with organizational priorities; Provide independent quality oversight and recommend improvements; Lead discussions with senior stakeholders to drive CAPAs; Analyse audit data and compliance trends; Serve as key partner during regulatory inspections; Coach and mentor auditors and business partners
Seniority
Senior, hands-on IC with strategic influence