Associate Director, Reliability And Product Improvement
CSL Behring
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Bachelor's degree in engineering
10 years pharmaceutical manufacturing experience
Leadership experience in team management
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CSL Behring is seeking an Associate Director of Reliability and Product Improvement to provide technical leadership for marketed combination products within their Drug Delivery Systems & Packaging division. The role involves collaboration across departments to enhance product reliability and compliance with regulatory standards.
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Job Summary
This role provides technical leadership to support marketed combination products within CSL's Drug Delivery Systems & Packaging division.
The incumbent ensures all sustaining activities comply with international 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.
Matching Summary
Match Score: 75
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CSL Behring is seeking an Associate Director of Reliability and Product Improvement to provide technical leadership for marketed combination products within their Drug Delivery Systems & Packaging division. The role involves collaboration across departments to enhance product reliability and compliance with regulatory standards.
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Skills & Requirements
Must-have
Bachelor's degree in engineering
10 years pharmaceutical manufacturing experience
Leadership experience in team management
Knowledge of ISO 13485 and ISO 14971
Experience with cGMP guidelines and validation
Understanding of device reliability and risk management
Nice-to-have
Cross-functional collaboration skills
Process automation knowledge
Supplier change management expertise
Technical project management proficiency
Ability to work with CDMOs
Key Requirements
Bachelor's in mechanical or chemical engineering
Minimum 10 years in parenteral or device manufacturing
Leadership experience in team supervision
Deep understanding of regulatory pathways for Health Authority submissions