Associate Director, Gxp Quality, Compliance And Audit - Evinova
Evinova
Hybrid
Gxp quality management system development
Gcp expertise in software development lifecycle
Planning and leading internal audits
Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector
Job Summary
Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector.
The Associate Director will lead the development and continuous improvement of the Quality Management System ensuring compliance with global regulatory standards.
Employees are expected to work from the office three days per week to foster connection, collaboration, and innovation.
Matching Summary
Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector.
Skills & Requirements
Must-have
GxP Quality Management System development
GCP expertise in software development lifecycle
Planning and leading internal audits
Supplier and third-party qualification and audits
Quality Issue Management and CAPA development
Regulatory inspection readiness
Cross-functional collaboration on GxP standards
Nice-to-have
Driving innovation in Quality and Compliance
Strong stakeholder management skills
Change leadership in complex environments
Mentoring and talent development
Confident communication and facilitation
Pragmatic decision-making
Resilient and proactive mindset
Key Requirements
Bachelor’s degree in Life Sciences or related field
5+ years pharmaceutical, biotech, or medical device experience
Strong knowledge of global GxP and GCP regulations
Experience with Quality Management Systems and SOPs
Health Authority inspection support experience
Proven GxP compliance and audit management
Experience with supplier qualification and CAPA management