The role is fully accountable for the quality of products manufactured at the Suzhou site and ensuring end-to-end compliance with global specifications and local Health Authority regulations
Job Summary
The role is fully accountable for the quality of products manufactured at the Suzhou site and ensuring end-to-end compliance with global specifications and local Health Authority regulations.
The incumbent serves as the Site Management Representative and Person Responsible for Regulatory Compliance equivalent under China Medical Device GMP regulations.
Roche fosters a culture of personal expression and open dialogue where every voice matters to prevent, stop, and cure diseases.
Matching Summary
The role is fully accountable for the quality of products manufactured at the Suzhou site and ensuring end-to-end compliance with global specifications and local Health Authority regulations.
Skills & Requirements
Must-have
Medical Device GMP regulations
NMPA FDA European regulatory compliance
Health Authority inspection readiness
ISO 13485:2016 quality management systems
Multi-jurisdictional audit leadership
Nice-to-have
Agile leadership behaviors
Servant-leadership principles
Lean management methodologies
Global network collaboration skills
Strategic business partnership abilities
Key Requirements
Bachelor's or Master's degree in Life Science or Pharmacy
At least 10 years in Medical Device/Pharma industry
Minimum 5 years experience in Quality, Compliance, or Regulatory functions
Demonstrated experience leading multi-jurisdictional audits
Expert knowledge of US, EU, and China cGMP regulations