Base: $196,000- $232,000; bonus/equity: not specif...
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Combination products and medical devices qa
Global quality system development
Design controls and risk management
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CSL Behring is seeking an Associate Director to lead its Quality Assurance department for Combination Products and Medical Devices. The role involves developing and managing the quality system, ensuring compliance with regulatory standards, and participating in strategic decision-making.
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Job Summary
The Associate Director is responsible for leading Quality for Combination Products and Medical Devices (CP/MD QA) global department that supports design, development, manufacture and regulatory approval of CSL combination products.
This role is accountable for the development, execution, and performance of the Global CP/MD Quality System for combination products in compliance with applicable regulations.
The Associate Director is expected to take part in defining the overall company strategy for the combination products, as well as the strategy for the CSL Global Quality.
Matching Summary
Match Score: 75
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CSL Behring is seeking an Associate Director to lead its Quality Assurance department for Combination Products and Medical Devices. The role involves developing and managing the quality system, ensuring compliance with regulatory standards, and participating in strategic decision-making.
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Salary
Base: $196,000- $232,000; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Combination Products and Medical Devices QA
Global Quality System development
Design Controls and Risk Management
Vendor Management and Auditing
Regulatory Compliance (21 CFR Part 4, 820, ISO 13485, MDR)
Nice-to-have
Strategic company vision
Cross-functional initiative leadership
Quality culture promotion
Key Requirements
Minimum 10 years experience in medical devices or combination products