Senior Director of Quality Systems & Compliance
Core
Overseeing strategic planning for large, complex Quality teams to ensure product and process compliance for pharmaceutical operations.
Role type
Senior Director of Quality Systems & Compliance (Pharmaceutical)
Builds
Pharmaceutical Quality System (PQS), compliant product specifications, and regulatory audit readiness.
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, CAPA management, root cause analysis, regulatory inspection leadership, budget management, team leadership, policy development, data analysis, project coordination
Preferred skills
Medical device experience, 10+ years in regulated industries (Pharma/Medical Device/Food/Cosmetic), advanced managerial experience
Technologies
Microsoft Excel
Responsibilities
Develop strategy for quality organizations, lead product specification development, advise leadership on QSR compliance, design and oversee PQS, govern quality system processes (CAPA, Change Control, Recall), manage training programs, partner on complaint handling, manage departmental budgets and staff
Seniority
Senior Director, strategic & operational leadership
