About the Role

　　Job Purpose:

　　The associate of Country QA QMS is responsible for managing quality aspects at quality system of Novartis Country Quality Japan with support from Head and/or Manager of Country QA QMS.

　　Ensure Novartis Country Quality Japan has the appropriate quality systems in place to meet regulatory and Novartis requirements for Novartis Country Quali-ty organization.

　　Ensure implementation of all local regulatory requirements for GxP areas in compliance with Novartis Quality Manual and in alignment with Industry Best Practices.

　　Diligently implement the annual Quality Plan and prevent any non-compliance issues and protect Novartis reputation.

　　Major Activities:

　　1. Act as Single Point of Contact / SPOC with support from Head and/or Manager of Country QA QMS for all quality related activities at Novartis Country Quality Japan.

　　2. Actively contribute the implementation of the Quality organization in Country, with high focus on compliance and efficiency.

　　3. Actively contribute to operational excellence projects in line with global process-streams and country quality strategy.

　　4. Actively contribute applicable Quality Standards and governance processes in-place and in-use through the Novartis Quality Manual implementation.

　　5. Actively contribute effective Key Quality Indicators in Country to monitor on a routine basis the relevant processes, ensuring control and compliance.

　　6. Prevent any potential compliance gaps and risks and ensure CAPAs will be punctually addressed.

　　7. Identify opportunities for continuous improvement and the punctual implementation of the annual Quality Plan at Country level.

　　8. Ensure Quality oversight within the Country for 3rd parties/vendors/outsourced activities in alignment with Head and/or Manager of Country QA QMS

　　9. Actively contribute adequate regulatory inspection preparation, management, and follow-up in the Country.

　　10. Ensure implementation of adequate GQP training within all relevant activities, based on adequate planning.

　　11. Actively contribute remediation activities for all existing compliance gaps, to ensure ongoing compliance.

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　Education (minimum/desirable):

　　Degree in Life Sciences, Pharmacy or Medicines. Demonstrated experience of successfully leading an organization or project of middle-high impact

　　Languages:

　　Fluency in English (oral and written); knowledge of languages spoken in the respective region is a plus.

　　Experience/Professional requirement:

　　2 or more years of Quality Assurance experience in the pharmaceutical industry and involvement in regulated activities; broad understanding of global expectations of Health Authorities in the GQP, GMP, GDP, PV regulated areas.

　　Strong interpersonal, communication, negotiation, and problem-solving skills

　　Project management skills

　　Division

　　Operations

　　Business Unit

　　QUALITY

　　Location

　　Japan

　　Site

　　Tokyo

　　Company / Legal Entity

　　Novartis Pharma K.K.

　　Functional Area

　　Quality

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No