Strategic Quality Partner

Roche

Not specified; not specified; not specified
**
Iso 13485 and gmp regulatory knowledge
End-to-end product lifecycle management expertise
Risk-based decision making capabilities
** Roche is seeking a Strategic Quality Partner who will leverage deep expertise in product lifecycle management and quality assurance to foster innovation and ensure compliance with regulations. The role emphasizes collaboration, effective communication, and the ability to guide change within product development processes while nurturing a culture of continuous improvement. **

Job Summary

  • The role requires deep expertise in regulations like ISO 13485 and GMP to ensure safe and compliant product development.
  • Candidates will act as a strategic partner to foster innovation, lead cross-functional projects, and drive effective change management within R&D.
  • Roche offers a culture that values personal expression and genuine connections while empowering employees to deliver life-changing healthcare solutions globally.

Matching Summary

Match Score: 75

** Roche is seeking a Strategic Quality Partner who will leverage deep expertise in product lifecycle management and quality assurance to foster innovation and ensure compliance with regulations. The role emphasizes collaboration, effective communication, and the ability to guide change within product development processes while nurturing a culture of continuous improvement. **

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • ISO 13485 and GMP regulatory knowledge
  • End-to-end product lifecycle management expertise
  • Risk-based decision making capabilities
  • Cross-functional project leadership skills
  • CAPA and Non-Conformance issue resolution

Nice-to-have

  • Agile collaboration and adaptability mindset
  • Coaching and mentoring team development
  • Innovation and continuous improvement culture
  • Global stakeholder relationship management
  • Knowledge management system implementation

Key Requirements

  • SE7 Global Grade level qualification
  • Proven experience in Pre-Market Quality functions
  • Ability to interpret global and local laws including China requirements

Work Rights

Not specified

Tailored Resume

Cover Letter