Associate Director, Quality Assurance (Toyama Talent)

Position Overview

Join the FUJIFILM Toyama Chemical facility in Toyama Japan! The Quality AssuranceAssociate Directorwillwork effectively independently and within a team framework across all business areas levels of the organization and with clients by delivering high quality at the right time to ensure timely delivery. This role requires that you can operate on both a strategic level with senior executives and to facilitate operational elements in the actual program execution.

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

Join FUJIFILM Biotechnologies and help make the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive - what we call Genki.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

An exciting opportunity awaits you as part of our Talent Transfer program to Toyama Japan! This role will be based on site in Toyama Japan. The Talent Transfer program offers several benefits such as building new relationships enhancing our culture of collaboration and gives you a unique opportunity for professional growth and are building a new KojoX facility scheduled to be completed by March 2027. This facility will provide comprehensive process development and manufacturing services for biopharmaceuticals ensuring we meet our customers evolving needs across Europe the US and Japan.

This assignment is scheduled for up to two years!

Principal Accountabilities:

• Client Responsibilities
  • Serve as primary point of contact for all Quality-focused communications with Clients: routine deviation and change control-related communications ensuring site personnel utilize the defined communication pathways communicating topics that may be difficult in nature in a calm and professional manner and issue resolution and conflict management.
  • Partner with the Program Management operations and QC including stability to ensure a unified message to Clients.
  • Assess and implement continuous improvement opportunities for existing systems as well as implementation of new systems for Client tracking and communications.
• PQS integrationResponsibilities
  • Support Global PQS integration and implementationby collaborating with FLB global network
  • Manage development implementation and continuous improvement of quality systems
  • Support improvement of validation/qualification programs and documentation
• Inspection ReadinessResponsibilities
  • Have the site ready for regulatory inspections such as FDA EMA and PMDA.
  • Improve training programs (e.g. Periodic Induction and Certification/Qualification) withComplianceWire
  • Perform Gemba walk to identify potential risk and do interactive SME training.
  • Keep current with required training and cGMP expectations for the site. Set monitor and report progress on goals and development activities
• General Responsibilities
  • Provide status reports and quality metrics to support management review.
  • Assist with the administration of the Quality systems as necessary.
  • Establish collaborative relationships with internal and external stakeholders to ensure timely documentation and resolution of quality issues.
  • Provide direction for complex technical documents.
  • Review & approve quality records.
  • Support client regulatory filings.
  • Assist QA senior management with departmental needs.

Minimum Education and Experience Required:

• 6 years of direct or indirect management experience
• Master of Science (.) or PhD with 8 years of applicable industry
• experience; or
• Bachelor of Science (.) with 10 years of applicable industry experience; or
• Associate Degreewith 12 years of applicable industry experience; or
• High school diploma with 15 of applicable industry experience

As part of any recruitment process FUJIFILM Biotechnologies collects and processespersonal data relating to job applicants. Theorganizationis committed to beingtransparent about how it collects and usesthat data and to meeting its data protection obligations and may share this as part of the global recruitment process withhiring managers in Europe Japan and the United States.

Required Experience:

Director

Employment Type : Full Time
Experience: years
Vacancy: 1