Associate Director, Reliability And Product Improvement

CSL Behring

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10 years pharmaceutical manufacturing experience
Iso 13485 and iso 14971 compliance knowledge
Leadership in team management and supervision
** CSL Behring is seeking an Associate Director for Reliability and Product Improvement to provide technical leadership in sustaining engineering for marketed combination products. The role requires extensive experience in the pharmaceutical industry, particularly in device manufacturing, and emphasizes compliance with regulatory standards and collaboration across various departments. **

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 are conducted in strict compliance with applicable standards including ISO 13485, ISO 14971, and 21 CFR Part 4.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and a culture of inclusion.

Matching Summary

Match Score: 75

** CSL Behring is seeking an Associate Director for Reliability and Product Improvement to provide technical leadership in sustaining engineering for marketed combination products. The role requires extensive experience in the pharmaceutical industry, particularly in device manufacturing, and emphasizes compliance with regulatory standards and collaboration across various departments. **

Skills & Requirements

Must-have

  • 10 years pharmaceutical manufacturing experience
  • ISO 13485 and ISO 14971 compliance knowledge
  • Leadership in team management and supervision
  • cGMP guidelines and validation practices expertise
  • Process automation and equipment reliability skills

Nice-to-have

  • Cross-functional collaboration with quality teams
  • Experience with CDMO evaluations and tech transfers
  • Strong risk management and change management skills
  • Ability to educate new product development leads

Key Requirements

  • Bachelor's degree in mechanical or chemical engineering
  • Minimum 10 years experience in parenteral or device manufacturing
  • Proven leadership experience in team management

Work Rights

Not specified

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