Associate Director, Reliability And Product Improvement
CSL
Not specified (assumed to be hybrid based on industry norms).
Bachelor's degree in engineering
10 years pharmaceutical manufacturing experience
Leadership experience in team management
CSL is seeking an Associate Director of Reliability and Product Improvement within its Drug Delivery Systems & Packaging division. This leadership role focuses on enhancing the safety and reliability of marketed combination products through technical guidance, regulatory compliance, and collaboration across teams
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 211.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.
Matching Summary
Match Score: 85
CSL is seeking an Associate Director of Reliability and Product Improvement within its Drug Delivery Systems & Packaging division. This leadership role focuses on enhancing the safety and reliability of marketed combination products through technical guidance, regulatory compliance, and collaboration across teams.
Skills & Requirements
Must-have
Bachelor's degree in engineering
10 years pharmaceutical manufacturing experience
Leadership experience in team management
Knowledge of cGMP guidelines and validation practices
Experience with ISO 13485 and ISO 14971 standards
Nice-to-have
Expertise in process automation and equipment reliability
Strong technical project management skills
Ability to collaborate with CDMOs and external organizations
Deep understanding of evolving regulatory landscape
Key Requirements
Bachelor's in mechanical or chemical engineering
Minimum 10 years in parenteral or device manufacturing