Associate Director, Global Clinical Distribution Quality

2 days ago

Bengaluru, India Vertex Full time

Job Description General Summary: The Associate Director, Global Clinical Distribution Quality role will work with the GMP Operational QA team to ensure that medicines are distributed in compliance with GDP and GMP requirements for Clinical Distribution. Key Duties and Responsibilities: Lead Clinical Quality Distribution team to support the Clinical Supply Chain activities, providing expert GDP support for clinical execution, pharmacy manual standards, ISR (investigator sponsored research) and home-dosing programs where necessary. Support the on-time completion of commitments for clinical supply including risk management, change control implementation, deviation/investigation review, and CAPA completion. Point of escalation for clinical site queries regarding handling and use of investigational product as it pertains to GDP Point of escalation for interactive response technology (IRT) issues related to clinical supply. Review and approval of GDP requirements in pharmacy manuals, IRT protocols and build verification, and distribution deviation records  Support inspection readiness and preparedness by ensuring all Clinical Product Distribution quality records and documentation are complete and provided to clinical supply colleagues. Create and own Vertex standards and best practices for clinical supply and execution. Ensure the supply of safe, compliant and effective finished product for all clinical programs in Vertex throughout the clinical program lifetime. Identify and trend Clinical Supply vendor compliance issues to drive action plans and improve both internal and external processes. Support regulatory inspection readiness and requests related to distribution and clinical site handling of investigational product Education and Experience: Significant experience supporting Clinical Supply vendor quality issue investigation, root cause analysis, CAPA, and effectiveness checks and associated records in quality management systems. Effectively manage quality relationships with external organizations, including distribution and IRT vendors and CROs. Develop and maintain quality agreements with Clinical Distribution Vendors. Support of GMP and GCP inspections with experience in the front room for FDA, EMA, and Swissmedic inspections. Point of escalation for all issues and clinical site queries related to the distribution and handling. Creation and ownership of Vertex standard operating procedures and best practices for clinical supply and execution. Quality and pharmacy SME to the clinical supply team to provide troubleshooting on clinical programs; providing expert GDP support for clinical trial execution, pharmacy manual standards, investigator sponsored research and home-dosing programs Bachelor's degree in relevant field is required Extensive years of experience or the equivalent combination of education and experience Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1.    Hybrid : work remotely up to two days per week; or select 2.    On-Site : work five days per week on-site with ad hoc flexibility.

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