Associate Director, Reliability And Product Improvement
CSL Behring
Not specified
10 years pharmaceutical manufacturing experience
Leadership in team management or supervision
Knowledge of iso 13485 and iso 14971 standards
CSL Behring is seeking an Associate Director for Reliability and Product Improvement within their Drug Delivery Systems & Packaging team. The role involves providing technical leadership to enhance the safety and reliability of marketed combination products while ensuring compliance with regulatory standards
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 and diverse workforce inclusion.
Matching Summary
Match Score: 85
CSL Behring is seeking an Associate Director for Reliability and Product Improvement within their Drug Delivery Systems & Packaging team. The role involves providing technical leadership to enhance the safety and reliability of marketed combination products while ensuring compliance with regulatory standards.
Skills & Requirements
Must-have
10 years pharmaceutical manufacturing experience
Leadership in team management or supervision
Knowledge of ISO 13485 and ISO 14971 standards
Experience with cGMP guidelines and validation practices
Expertise in device reliability and risk management
Nice-to-have
Ability to collaborate with external organizations
Strong technical project management skills
Deep understanding of evolving regulatory landscape
Experience with tech transfers and CDMO evaluation
Key Requirements
Bachelor's degree in engineering (mechanical or chemical preferred)
Minimum 10 years of experience in parenteral or device manufacturing
Leadership experience in team management or supervision
Knowledge of process automation and equipment reliability