Senior Quality Associate

CSL Behring

Base: $94,000 - $111,000; bonus/equity: incentive ...
Gmp regulatory compliance knowledge
Deviation and oos investigation management
Change control process facilitation
The role ensures compliance with GMP/GSP/GxP by providing quality guidance across all phases of Technical Product Development for the CSL Clinical development portfolio

Job Summary

  • The role ensures compliance with GMP/GSP/GxP by providing quality guidance across all phases of Technical Product Development for the CSL Clinical development portfolio.
  • Candidates will manage complex deviations, facilitate Deviation Review Board meetings, and oversee change controls to ensure regulatory adherence.
  • CSL Behring is a global biotherapeutics leader employing 32,000 people who delivers lifesaving therapies to over 100 countries.

Matching Summary

The role ensures compliance with GMP/GSP/GxP by providing quality guidance across all phases of Technical Product Development for the CSL Clinical development portfolio.

Salary

Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • GMP regulatory compliance knowledge
  • Deviation and OOS investigation management
  • Change control process facilitation
  • Product technical complaint handling
  • Self-inspection execution and reporting

Nice-to-have

  • Strong interpersonal negotiation skills
  • Experience with Clinical Trial GMP manufacture
  • Ability to work independently and self-motivate
  • Good analytical problem solving skills
  • Customer focus orientation

Key Requirements

  • Degree in biological science
  • At least 3 years experience in manufacturing, Regulatory Affairs, QA, or Process Development
  • Previous Production, Quality or R&D experience within Pharmaceutical industry

Work Rights

Not specified

Tailored Resume

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