Key Responsibilities
* Supervise compliance and customer quality agreement activities for drug product operations
* Establish and negotiate quality agreements in collaboration with relevant teams
* Serve as the primary point of contact for quality assurance-related inquiries and complaints from customers
* Manage interactions regarding changes, deviations, technical complaints, and out-of-specification results
* Represent quality assurance in cross-functional teams and maintain effective interfaces with manufacturing, quality control, and engineering teams
* Act as the quality assurance representative in project teams and customer meetings during technical transfers
* Support and facilitate project-specific risk assessments and regulatory gap assessments
* Review and release product-specific documentation, including process descriptions, manufacturing protocols, and test plans
* Collaborate closely with quality control project leaders and support new product introductions
* Assess, review, and approve quality records such as deviations, change controls, and corrective actions
* Author, review, and approve GMP-relevant documents and standard operating procedures