Associate Director, Market Product Quality 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 build, develop and educate the organization, both internally and externally

Minimum Requirements

Minimum 5 years' experience in pharmaceutical recall management. 7- 10 years' experience in pharmaceutical Quality & Compliance organization. Experience developing and/or managing quality systems & processes. Required expertise of FDA GxP regulations for pharmaceutical products and recall management. In-depth knowledge of GMP requirements of Global Supply Chain Security Program, including Serialization, e-pedigree, Anti-Counterfeiting technology, and Product Authentication.

Expert understanding of FDA GxP regulations and other major Health Authorities. Prior experience in the implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities. Prior experience in Recall Management. In-depth knowledge of GMP requirements of Global Supply Chain Security Program, including Serialization, e-pedigree, Anti-Counterfeiting technology, and Product Authentication. Demonstrated ability to build trusting relationships with senior management and other business stakeholders. Demonstrated business acumen and ability to identify stakeholders needs and adapt communications style. Demonstrated ability to develop and communicate a vision for an organization and motivate others to follow. Demonstrated ability to initiate and drive organizational change in complex matrix environment. Ability to lead others through change, effectively manage resistance, and ensure organizational engagement. Ability to influence and drive/facilitate change across the organization. Demonstrated track-record of operational leadership across multiple sites in the Quality function Extensive track record of successful cross-divisional/cross-functional work with complex and multidisciplinary teams Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude. Proven self-starter with experience in initiating and delivering high impact projects and processes across a geographically and functionally diverse teams. Self-motivated with a high degree of ownership and accountability for results. Outstanding facilitation skills for bridging between scientific and business stakeholders, and for managing effective and successful international and cross-divisional collaborations. Demonstrated strength in applying strategic thinking, scenario evaluation and contingency planning. Excellent communication, negotiation, consulting/facilitation, and interpersonal skills. Strong organizational awareness and business acumen (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.

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