Roche fosters a culture encouraging personal expression, open dialogue, and genuine connections, valuing individuals for their unique qualities
Job Summary
Roche fosters a culture encouraging personal expression, open dialogue, and genuine connections, valuing individuals for their unique qualities.
The Local Quality Responsible is accountable for implementing the Affiliate Quality Management System and ensuring local Medical Compliance activities align with global standards and local regulations.
This role involves leading inspection readiness, risk and opportunity management, and continuous improvement initiatives to maintain the affiliate License to Operate.
Matching Summary
Roche fosters a culture encouraging personal expression, open dialogue, and genuine connections, valuing individuals for their unique qualities.
Skills & Requirements
Must-have
Quality Management System (QMS) implementation
Medical Compliance and Risk Management
CAPA management process leadership
Audit and Inspection readiness
Service Provider oversight
Cross-functional team collaboration
Nice-to-have
Strategic mindset and system thinking
Strong verbal and written communication skills
Familiarity with Agile methodology
Data analytics and qualitative insights
Strong partnering and networking capabilities
Experience with international networks
Key Requirements
Bachelor's Degree in Life Science or equivalent
More than 5 years experience in biopharmaceutical industry
Applied knowledge of ICH GCP, GVP, and relevant regulations
Understanding of ISO 9001, ISO 31000, ISO 13485 standards
Experience in audits and Health Authority inspections preferred