Associate Director, Reliability And Product Improvement
CSL SEQIRUS
Not specified
Bachelor's degree in engineering
10 years pharmaceutical manufacturing experience
Leadership experience in team management
CSL Seqirus is seeking an Associate Director of Reliability and Product Improvement to lead technical initiatives for marketed combination products within their Drug Delivery Systems & Packaging division. The role involves collaborating with various departments to optimize processes, ensure compliance with regulations, and drive design improvements while maintaining a strong focus on safety and reliability
Job Summary
This role provides technical leadership to support marketed combination products within the Drug Delivery Systems & Packaging division.
The position 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 Seqirus is seeking an Associate Director of Reliability and Product Improvement to lead technical initiatives for marketed combination products within their Drug Delivery Systems & Packaging division. The role involves collaborating with various departments to optimize processes, ensure compliance with regulations, and drive design improvements while maintaining a strong focus on safety and reliability.
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
Experience with ISO 13485 and ISO 14971 standards
Nice-to-have
Process automation expertise
Equipment reliability knowledge
Cross-functional collaboration skills
Risk management and change management
Supplier relationship management
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 and audits