Representative, Quality Unit (qs Manager)

Zeiss Group

Not specified; not specified; medical, vision, den...
Fully remote
21 cfr 210/211 drug regulations
21 cfr 111 dietary supplement regulations
Sterile product quality oversight
The role serves as the designated Quality Unit representative with ultimate responsibility for product quality and regulatory compliance across a diverse portfolio of regulated products

Job Summary

  • The role serves as the designated Quality Unit representative with ultimate responsibility for product quality and regulatory compliance across a diverse portfolio of regulated products.
  • Candidates must maintain a robust Quality Management System compliant with FDA regulations for drugs, dietary supplements, and cosmetics while overseeing contract manufacturers.
  • ZEISS offers world-class benefits including medical, vision, dental, 401k matching, and vacation pay starting from the first day.

Matching Summary

The role serves as the designated Quality Unit representative with ultimate responsibility for product quality and regulatory compliance across a diverse portfolio of regulated products.

Salary

Not specified; Not specified; Medical, Vision, Dental, 401k Matching, Vacation and sick pay included

Skills & Requirements

Must-have

  • 21 CFR 210/211 Drug regulations
  • 21 CFR 111 Dietary Supplement regulations
  • Sterile product quality oversight
  • Contract manufacturer qualification
  • Adverse Event Reporting (AER)
  • Batch record review and release

Nice-to-have

  • MoCRA cosmetic regulation knowledge
  • RAC certification preferred
  • CQA or CQM/OE certification desirable
  • Risk assessment tools like FMEA
  • Virtual quality management experience

Key Requirements

  • Bachelor's degree preferred
  • 7-10 years QA or Regulatory Affairs experience
  • Experience with sterile manufacturing oversight
  • Knowledge of MoCRA and DSHEA updates
  • Experience submitting Adverse Event reports to FDA

Work Rights

Not specified

Tailored Resume

Cover Letter