[Janssen / Quality]Operational Quality Senior Manager, Operational Quality

Auris Health

Auris Health

Quality Assurance
Posted on Wednesday, April 5, 2023
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The Quality Operation's Senior Manager has 2 main responsibility. First responsibility is supporting and providing guidance to the team's overall direction based on the Site and Quality's Goals and Objective. Guidance ranges from assisting team members participating in the quality on the shop floor with emphasis on compliance and safety, daily quality decision at the Fuji Plant in collaborating with manufacturing and other support functions to improve the overall quality assurance in the production environment. This position will also require to host regular meetings with the sourcing sites to address Japan Quality Requirements supporting the operational quality supervisors to achieve the needs of our patients in the market we serve. Second key responsibility is to support the site Quality Lead in regional and global discussions on items ranging from overall strategy, quality projects to talent development.

The quality team is composed of diverse members, and we at Fuji is focused on diversity, equity and inclusion, and we value each members' opinion!

Regulatory compliance responsibilities:

This role requires the understanding and follow the Act on Securing Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices, etc., GMP, GCTP, Narcotics and Psychotropics Control Law, and other related laws and regulations, corporate policies, and procedures.

Job details:

Your will be responsible to providing oversite and support to your team during production (Product Quality and Quality Compliance) in collaboration with your direct supervisors, guide and educate subordinates and operations on good quality practices and data integrity preparing the site for any health authority audits. You will be taking quality decisions on issues occurring during manufacturing and review any quality issues raised within understanding of the Japanese regulatory requirements. In addition, this position requires to conduct routine meetings to promote Japan quality and requirements with our external partners.

This role will also participate in key quality global and regional meetings, from strategy, compliance initiatives to people agenda.

Why work with Janssen

At Janssen, we will work together to creating a future where disease is a thing of the past! Working together to serve our patients through our Credo. We are also committed to the well being and development of our employees.

Why work in quality? Gaining experience in quality will enable to flourish your career in different roles such as quality systems or compliance and MAH quality to broaden the scope in this industry beyond the manufacturing site.


Education / Experience: (Required)


Quality experience in the pharmaceutical and/or medical device industry

Experience in operating a quality management system

Education / Experience: Pharmacy, Bacteriology or Microbiology

Soft Skills:

  • Value our Credo
  • Always follow our EHS (Environment, Health and Safety) rules and procedures
  • Communication with site and global partners, teamwork and partnership
  • Developing business with customer first mentality
  • Learning agility

Qualifications and skills:

  • Pharmacist degree or Masters in Bacteriology or BS in Microbiology
  • Experience working in a pharmaceutical or medical device manufacturing facility.
  • Experience with quality systems useful (Trackwise, Document Management System, Leaning Management System)
  • Data visualization tools for business intelligence
  • English skill (Hosting or Facilitating meetings and managing global partners)


  • N/A

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

*Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).