Johnson & Johnson Careers

【Janssen】Business Quality Manager

Chiyoda, Japan
Quality Assurance


Job Description

Requisition ID: 1700190501W

<Responsibilities include, but not limited to:>
 
  • Ensure consistency of the manufacturing, specifications and test methods with the registered dossiers in Japan.
  • Lead corrective and preventive actions to maintain compliance status with the registered dossiers in Japan.
  • Maintain Quality Agreement with External Manufactures, Contract Laboratories and Logistic Service Providers as needed
  • Contribute to the BQ mission, vision and strategy
  • Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
  • Support GxP system (CAPA, Change Control, Deviation, Quality issue, Training etc.)
  • Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.
  • Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products.
  • Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / or Import Licenses are available and kept up to date for all marketed products.
  • Conduct regular (self-) inspections that are applicable on the supply chain within the responsibilities of the LOC.
  • Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.


Qualifications
 

<Work Experience>

  • +7 years of directly related experience in quality assurance and quality related activities., or Johnson & Johnson
  • Experience with Japanese pharmaceutical companies
 

<Necessary Skills>

  • Excellent communication skills both in English and Japanese
  • Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.
  • Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
  • Project management skill
  • Advanced degree (MS, MBA, PhD) preferred
 
<Qualification>
it is preferred
  • Have experience in manufacturing, product quality, CMC, RA or GXP audit
  • Have a pharmacist’s license
 
<Character>
  • Leadership to challenge the status quo and how things have always been done.
  • Leadership and motivation with high personal integrity and application of J&J Credo Values in daily operations.
  • Leadership experience leading projects, programs or other global initiatives
  • Can show his/her agility even in a new work area.
  • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders


Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Quality Assurance
Requisition ID
1700190501W