Director, GPS Quality & Compliance
Core
Lead functional workstreams for quality event management and inspection readiness programs, serving as a trusted point of contact during regulatory audits.
Role type
Director, Quality & Compliance (Functional Leader)
Builds
Inspection readiness materials, quality metrics programs, and cross-functional quality oversight frameworks.
Domain
Pharmaceutical industry, Global Pharmacovigilance (PV), Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Global PV regulations expertise, Quality Management Systems (QMS), FDA/EMA/MHRA inspection facilitation, QMP governance, Cross-functional stakeholder management, Data analysis for quality metrics
Preferred skills
Healthcare Professional background, People management experience, Advanced degree
Technologies
FDA CFR, GVP Modules
Responsibilities
Lead functional workstreams across quality event management and inspection programs, Serve as a trusted point of contact during GCP and GVP audits and inspections, Maintain inspection readiness materials and translate regulatory frameworks into practical action, Review quality metrics and trend analyses to shape actionable recommendations for senior leadership, Coordinate and delegate work across the team to ensure consistent program delivery, Manage relationships across GDQ, QPPV Office, Regulatory Affairs, and vendors
Seniority
Director, functional leadership with 12+ years experience
