Associate Director, Reliability And Product Improvement

CSL Behring

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Bachelor's degree in engineering
10 years pharmaceutical manufacturing experience
Leadership in team management
** CSL Behring is seeking an Associate Director of Reliability and Product Improvement to lead technical initiatives that enhance the safety and reliability of marketed combination products. This role involves collaboration across multiple departments and adherence to regulatory standards, requiring extensive experience in the pharmaceutical manufacturing sector. **

Job Summary

  • This role provides technical leadership to support marketed combination products within CSL's Drug Delivery Systems & Packaging division.
  • The position ensures all sustaining activities comply with international standards including ISO 13485, ISO 14971, and 21 CFR regulations.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and diverse workforce inclusion.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director of Reliability and Product Improvement to lead technical initiatives that enhance the safety and reliability of marketed combination products. This role involves collaboration across multiple departments and adherence to regulatory standards, requiring extensive experience in the pharmaceutical manufacturing sector. **

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 10 years pharmaceutical manufacturing experience
  • Leadership in team management
  • Knowledge of ISO 13485 and 21 CFR Part 4
  • Experience with cGMP guidelines

Nice-to-have

  • Cross-functional collaboration skills
  • Process automation knowledge
  • Risk management expertise
  • Supplier change management
  • Regulatory submission support

Key Requirements

  • Bachelor's in mechanical or chemical engineering
  • Minimum 10 years parenteral/device manufacturing experience
  • Proven leadership experience in supervision
  • Deep understanding of evolving combination product regulatory landscape

Work Rights

Not specified

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