Representative, Quality Unit (qs Manager)

Carl Zeiss Pty Ltd

Fully remote
7-10 years qa or regulatory experience
Knowledge of 21 cfr 210/211 and 111
Sterile product quality oversight
Carl Zeiss Pty Ltd is seeking a Representative for their Quality Unit, responsible for overseeing the Quality Management System for a diverse portfolio of regulated products. The ideal candidate will have extensive experience in Quality Assurance or Regulatory Affairs, particularly in the pharmaceutical or dietary supplement sectors, and will manage quality complaints and regulatory compliance

Job Summary

  • The successful candidate will serve as the designated Quality Unit representative with oversight of the Quality Management System for a diverse portfolio of regulated products.
  • This role manages the Tier 2 Customer Care function, serving as the escalation point for quality complaints, medical inquiries, and Adverse Event Reporting.
  • ZEISS offers world-class benefits including medical vision dental coverage, 401k matching, and vacation pay from the first day.

Matching Summary

Match Score: 85

Carl Zeiss Pty Ltd is seeking a Representative for their Quality Unit, responsible for overseeing the Quality Management System for a diverse portfolio of regulated products. The ideal candidate will have extensive experience in Quality Assurance or Regulatory Affairs, particularly in the pharmaceutical or dietary supplement sectors, and will manage quality complaints and regulatory compliance.

Skills & Requirements

Must-have

  • 7-10 years QA or Regulatory experience
  • Knowledge of 21 CFR 210/211 and 111
  • Sterile product quality oversight
  • Batch record review and release
  • Adverse Event Reporting (AER) management

Nice-to-have

  • Experience with MoCRA cosmetic regulations
  • RAC or CQA certification
  • Virtual Quality Management skills
  • Risk assessment tools like FMEA
  • Strong communication for training staff

Key Requirements

  • Bachelor's degree preferred
  • Minimum 7-10 years experience in Pharmaceutical or Dietary Supplement industry
  • Experience with sterile manufacturing or quality oversight
  • Knowledge of FDA facility registrations and product listings

Work Rights

Not specified

Tailored Resume

Cover Letter