Join the FUJIFILM Toyama Chemical facility in Toyama, Japan! The Quality Assurance Associate Director will work 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. 

The work we do at FUJIFILM Biotechnologies has never been more important—and 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 people’s 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 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

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 development.   In Toyama we 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 to last one year (364 days).

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 integration Responsibilities
  • Support Global PQS integration and implementation by collaborating with FLB global network
  • Manage development, implementation, and continuous improvement of quality systems
  • Support improvement of validation/qualification programs and documentation 

• Inspection Readiness Responsibilities 
  • Have the site ready for regulatory inspections such as FDA, EMA and PMDA. 
  • Improve training programs (e.g. Periodic, Induction and Certification/Qualification) with ComplianceWire
  • 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 (M.Sc.) or PhD with 8+ years of applicable industry 
• experience; or 
• Bachelor of Science (B.Sc.) with 10+ years of applicable industry experience; or 
• Associate Degree with 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 processes personal data relating to job applicants. The organization is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe, Japan, and the United States.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).