• Build and maintain robust quality program that will effectively support clinical and commercial manufacturing operations; • Conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved; • Interpret Regulatory Authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to improve compliance processes and procedures; • Direct the review and approval of the Quality Manual, Quality Policies, Protocols, SOPS, Batch Records, Test Methods, Raw Material Specifications, and Annual Product Reviews and CAPAs; • Ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust Change Control system and procedures are developed and maintained to meet worldwide regulatory standards; • Develop and execute Site QA operating and capital budgets and manage department efforts to control costs within approved levels; • Provide leadership and managerial oversight to the quality department. Develop staff and work closely with them to ensure that a consistent approach is taken in evaluation and resolution of quality issues.
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