Associate Director, Market Product Quality

Sandoz Inc. • Princeton, NJ • 2d ago

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.Join us as a Founder of our 'new' Sandoz!As the Associate Director, Market Product Quality you will be responsible for the execution of processes related to the removal of products from the market in accordance with Sandoz Quality procedures and FDA regulations. Responsible for the execution of processes related to Health Authority reporting for Sandoz in accordance with Sandoz Quality procedures and US Regulations. Responsible for managing a compliant framework of GMP policies, directives, procedures and processes that support the Global Supply Chain Security program, including Serialization, Anti-Counterfeiting, and Product Authentication.Your additional responsibilities include, but not limited to: Participate in Product Quality Escalation Meetings to facilitate the timely filing of Health Authority reports (i.e., FARs, BPDRs, Form 3911s) Provide guidance to colleagues concerning the Recall process and regulations. Coordinate and Provide information to FDA as necessary or requested regarding filed reports and recall investigations. Coordinate follow-up activities from Product Quality Escalation meetings as part of the event investigation as required. Facilitate and track the progress of Escalated events, Health Authority reports, and Recall audit checks as needed. Act as a liaison with partner entity recall coordinators and FDA. Maintain a shareable electronic database program which will be used for all Escalation, Health Authority reports, and Recall tracking for historical review. Monitor FDA communications for impact to Sandoz rules and policies.\Supports the organization's compliance with DEA regulations, including required reporting, audit support and guidance/support to colleagues as needed.\ Execution and enforcement of Recall policies and procedures. Communicate Recall activities, actions, and requirements to internal stakeholders. Provide recall technical guidance to stakeholders during a Recall event. Coordinate Recall actions and activities with FDA as needed. Provide Quality and Compliance oversight and support for Sandoz, Inc. commercial product. Assist leadership to design, implement, and sustain a robust and compliant framework of GMP policies, directives, procedures, and processes that support the Global Supply Chain Security program, including Serialization, Anti-Counterfeiting, and Product Authentication. Assist with establishment of a sustainable strategy for the Global Supply Chain Security program. Maintain awareness of evolving Supply Chain Security regulations and trends and implement systems to address potential GMP compliance impact. Communicate effectively and build cooperative and supportive working relationships with Serialization, and Corporate Security team, sites, and cross-functional departments. Actively participate in pharmaceutical industry meetings, symposia, and workshops to establish industry relationships, best practices, and regulatory guidance as related to Supply Chain Security. Establish and maintain the Global Quality Supply Chain Security metrics.Provide consistent and timely slides and metrics for KQIs on market product quality, compliance with the Quality Manual, and SOP/GOP implementation as needed (examples include Quality Management Review, town halls, etc.).* Identify and recommend appropriate actions, activities, and projects for continuous improvements.Support initiatives/activities that b

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