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Johnson & Johnson キャリア

【Medical】ビジネスクオリティーマネージャー

千代田区, 日本
Quality (Eng)


仕事内容

Requisition ID: 1805699622W

Business Quality
 
  • Provide subject matter expertise facilitating the business proposal and technical evaluation and supplier management process to fulfill market specific solutions needs in JJKK and ASPAC region.
  • Operate as a key business partner for quality and process improvement, understand business requirements and execute market specific solutions to drive organization capability building.
  • Work with source operating companies to implement respective Quality System responsibilities and assure appropriate communication channels are created and maintained.
  • Leverage knowledge, resources to transfer or scale up  J&J proven quality programs and process in JJKK and within the region.
  • Support compliance to all J&J Quality Policy and Technical Standards and regulatory requirements where applicable.
  • Development and monitor the appropriate product and process performance measures/targets.
 
 
Operational
 
  • Participate, support or lead APR process and quality improvement project when applicable.
  • Communicate and engage commercial leaders, champions, process owners and project teams about applying BQ processes and procedures.
  • Demonstrates ability to develop and implement corrective / preventative action and mitigation plan recommendations.
 
 
Relationship Management
 
  • Explore, identity, connect and maintain network with franchise SMEs  to  socialize,  learn and align  applicable J&J quality and compliance requirement
  • Communicate and partner with JJKK and other LOC stakeholders (QRC, commercial, process owner etc) to execute the applicable requirement.
 
 
SPECIFIC COMPETENCIES:
 
 
External Processes
 
  • Supplier management process.
  • MHLW process on pre-market product registration and post market surveillance process,  MAH responsibility and MD Good Distribution Process.
  • Familiar with international or Japan Industrial standards
 
 
Local Market Acumen
 
  • The ability to understand and adhere to key local market compliance standards to meet quality requirements and market needs, such as product licensing & authorizations, labeling regulations, repackaging / relabeling procedures, local market promotion / marketing compliance, etc.
 
Communication
 
  • Demonstrate ability on succinct and clear communicate with commercial and business partner .
  • Demonstrates ability to work in a matrix reporting and cross-cultural environment
 


資格
QUALIFICATIONS:
 
  • Bachelors or master’s degree in Biosciences or Engineering or equivalent field
  • Relevant experience in the regulated industries in product design, development or transfer, or manufacturing environment or APR process.
  • Technical knowledge or experience in sterility, computer system validation etc.  
  • Experience with project management.
  • Influence and interact at multiple levels of the organization.
  • Ability to manage multiple priorities and deliver excellent results.
  • Excellent written and verbal communications skills.
 
 
DESIRABLES
 
  • ISO13485 or equivalency lead auditor qualification 


プライマリ場所
日本-東京都-千代田区-
組織
Johnson & Johnson K.K. (8235)
ジョブ
Quality (Eng)
Requisition ID
1805699622W