As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP and applicable regulations with high autonomy
Job Summary
As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP and applicable regulations with high autonomy.
You will design and maintain quality systems, conduct audits and inspections, manage risks and CAPAs, and enable change processes and training.
The company offers a vibrant, innovative environment that encourages new ideas and collaboration, committed to advancing medical science and patient outcomes.
Matching Summary
As Especialista em Assuntos Médicos, you will lead quality governance end-to-end, ensuring compliance with BcP/GcP and applicable regulations with high autonomy.
Skills & Requirements
Must-have
Quality system design and governance
Audit and inspection management
Deviation and CAPA investigations
GxP system validation and compliance
Risk management and mitigation
Change control governance
Stakeholder and supplier management
Nice-to-have
Training development and delivery
Data integrity and compliance culture
Dashboard and KPI monitoring
Collaboration with clinical operations
Advanced English communication
Excel proficiency for analysis
Key Requirements
Higher education in Pharmacy, Nursing, Biomedicine, Medicine or related
Solid experience in Quality focused on GcP/BcP and Clinical Research
Experience in audits, inspections, and compliance
Expertise in deviation investigations and CAPA management
Experience with GxP system validation and document governance