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
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
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.
Salary
Base: $196,000- $232,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified
Skills & Requirements
Must-have
Combination Products and Medical Devices QA
Global Quality System development and execution
Design Controls and Risk Management
Vendor Qualification and Auditing
Regulatory compliance (21 CFR Part 4, 820, ISO 13485, MDR)
Nice-to-have
Strategic company vision contribution
Cross-functional initiative leadership
Quality culture promotion
Key Requirements
Bachelor’s degree in relevant engineering or life science discipline
10+ years of experience in medical devices or combination products
2+ years of people management experience
Experience in managing multi-site locations preferred
Experience in budgeting and financial management preferred