Sr. Manager, Quality Assurance Compliance

467

Irvine, California, United States
Onsite
Bachelor's degree or equivalent experience
Fluent english communication skills
Gxp compliance and cgmp knowledge
This role serves as a key Quality leader at the Irvine Technology Center responsible for strengthening site quality systems and compliance posture

Job Summary

  • This role serves as a key Quality leader at the Irvine Technology Center responsible for strengthening site quality systems and compliance posture.
  • The position acts as the Deputy Person Responsible for Regulatory Compliance (Deputy PRRC) supporting EU MDR obligations and regulatory risk escalation.
  • Alcon offers a robust benefits package including health, life, retirement, flexible time off, and opportunities for focused career growth.

Matching Summary

This role serves as a key Quality leader at the Irvine Technology Center responsible for strengthening site quality systems and compliance posture.

Skills & Requirements

Must-have

  • Bachelor's Degree or equivalent experience
  • Fluent English communication skills
  • GxP compliance and cGMP knowledge
  • ISO standards implementation
  • Audit readiness and inspection leadership

Nice-to-have

  • Experience with MES, SAP, Trackwise, Teamcenter
  • Deputy PRRC responsibilities under EU MDR
  • Cross-functional collaboration in manufacturing
  • Continuous improvement process execution
  • Team development and mentorship capabilities

Key Requirements

  • 10 years of relevant experience preferred
  • 5 years of demonstrated leadership experience
  • Bachelor's degree or equivalent years of experience
  • Fluency in reading, writing, and understanding English

Work Rights

Not specified

Tailored Resume

Cover Letter