Combination Products and Medical Devices QA Lead

Job description

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, which include medical device constituent part(s) as well as the audit program to evaluate quality. 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 Quality System under the leadership of this role must define / govern quality related business processes throughout the entire combination product lifecycle, with the emphasis on the new product development activities. 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. Reports To: Head, R&D Quality: Direct Reports: Regional Quality Engineer Combination Products and Medical Devices RESPONSIBILITIES AND ACCOUNTABILITIES: 1 . Develop, implement and manage Global CP/MD Quality System compliant with the relevant regulations, such as 21 CFR Part 4, applicable chapters...