Leitung Qualitätsmanagement - Pharma / GDP / GMP (m/w/d)
Core
Strategic leadership of GDP-compliant Quality Management (QM) system and Responsible Person (RP) duties for a pharmaceutical company, ensuring regulatory compliance and quality documentation.
Role type
Senior Quality Management Lead / Responsible Person (RP)
Builds
GDP/GMP-compliant quality management systems and documentation
Domain
Pharmaceutical industry / Regulatory compliance
Required skills
Pharmaceutical Quality Management, Regulatory Affairs (AMG, AM-HandelsV, EU-GDP, EU-GMP), Change Control, CAPA, Risk Management, Audit Management, Internal/External Audits, Management Reviews, KPI Reporting, Responsible Person (RP) certification
Preferred skills
International environment experience, Outsourced business models experience
Technologies
None stated
Responsibilities
Strategically build and develop the GDP-compliant QM system, manage quality-critical processes (Change Control, CAPA, Risk Management), lead corrective actions for deviations, prepare Management Reviews, act as central contact for regulatory authorities, plan and lead internal/external audits, accompany authority inspections
Seniority
Senior, hands-on IC
