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Has responsibility for the development, implementation, monitoring and improvement of one or more Quality Systems related to policies and procedures, performance measurement, continuous improvement, capability and development and validation of our systems and processes. Systems include consumer comments, learning and development, investigations, validation, etc.
Demonstrated knowledge of FDA cGMP requirements for OTC drugs and dietary supplements.
Demonstrated experience with Quality Program Health Assessment (Self-Improvement Plan).
Demonstrated strong internal and external collaboration and communication skills.
Demonstrated understanding of risk assessment and management-understands concepts of ICH-Q9 and how to practically administer at the site
Demonstrated ability to host audits (regulatory, internal)
Demonstrated ability to manage and coach people
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