【Vision Care】Quality & Regulatory Compliance Director in Chiyoda, Tokyo-To | DiversityInc Careers
 
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【Vision Care】Quality & Regulatory Compliance Director


Position (“Position”) is responsible for overall quality and compliance leadership in Japan for Johnson & Johnson Vision Care (JJVC) and Vision Surgical (JJVS), Johnson & Johnson Vision (JJV).  This role will report directly to J&J Vision Sr. Director Regional QA and Business Quality, and serve on applicable Japan VC and/or VS commercial LTs as appropriate. This includes all JJV related distribution centers, QMS systems, applicable customer call centers and compliant handling organizations, vigilance reporting, QC inspections, warehouses and third party logistic operations affiliated with JJV. 

 
  • Lead effective implementation of Quality Management System for Consumer business in Japan.  Ensure ongoing compliance to local regulations for all J&J products marketed by Consumer Local Operating Company (JJKK) in Japan. This includes the ownership of GQP and GMP responsibilities for all product categories being commercially distributed/sold in Japan market.
 
  • Lead Quality Systems Management Review, Product review, Quality Management Committee (i.e. Quality Review Board), Product Discontinuations and Field Actions for the Japan LOC.  Actively partner with various functions within Japan and in Asia Pacific (Japan Leadership Team, Supply Chain, Regulatory Affairs, R&D, Marketing, Sales, Distribution etc.) to meet business objectives.
 
  • Ensure implementation of end-to-end complaints vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS, and track needed actions to address adverse trends.
 
  • Lead preparedness of LOCs for regulatory inspections/audits, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations.
 
  • Keep country management aware of Quality and Compliance related issues/systems through periodic Management Review Process and issue escalation.
 
  • Position will be accountable for designing and implementing successful quality and compliance strategies which will ensure superior Japan customer experience, compliance and the meeting of business goals and objectives.  Position will serve as Sokatsu for Japan Vision.
 
  • Manage and develop a capable organization. Be responsible for budget, staffing, career planning, training & development and providing for a safe & pleasant working environment for all quality employees. Ensure acceptable behavior and performance by the Quality team.
 
  • Position will partner heavily with JJV Franchise Quality including Vision Life Cycle Management organization (such as Product Quality Directors), Regional JJVC and JJVS leadership (including Commercial), Regional Business Quality organizations for J&J, CLS where needed, and the Johnson & Johnson Enterprise quality organization to drive improvements in quality and compliance for Japan. 
 
  • Accountabilities also include all JJV Quality & Regulatory compliance in the region including ensuring successful relationships and communications with MHLW, TMG and other Japan applicable government bodies.
 
  • Position will ensure the Quality Management System (QMS) complies with all external regulatory requirements in accordance with Japan JPAL regulations and associated ISO standards, as well as internal Johnson & Johnson Enterprise and JJV Franchise requirements. 
 
  • Responsibilities also include proactively monitoring, analyzing and improving all aspects of quality compliance, quality control and customer complaint process to drive the Total Customer Experience. Responsible for escalation of relevant issues within the region to the Franchise, facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint process, and all quality assurance components of the QMS in Japan.
 
  • Position will be held accountable for effective and efficient communications to all relevant partners within Japan J&J, especially J&J Vision (Vision Care and Vision Surgical), as well as fostering a QA organizational culture which is high performance, inclusive, collaborative, transparent, and CREDO based.
 
  • Accountable for leading an organization size of approximately 50 to 75 personnel

Position (“Position”) is responsible for overall quality and compliance leadership in Japan for Johnson & Johnson Vision Care (JJVC) and Vision Surgical (JJVS), Johnson & Johnson Vision (JJV).  This role will report directly to J&J Vision Sr. Director Regional QA and Business Quality, and serve on applicable Japan VC and/or VS commercial LTs as appropriate. This includes all JJV related distribution centers, QMS systems, applicable customer call centers and compliant handling organizations, vigilance reporting, QC inspections, warehouses and third party logistic operations affiliated with JJV. 

 
  • Lead effective implementation of Quality Management System for Consumer business in Japan.  Ensure ongoing compliance to local regulations for all J&J products marketed by Consumer Local Operating Company (JJKK) in Japan. This includes the ownership of GQP and GMP responsibilities for all product categories being commercially distributed/sold in Japan market.
 
  • Lead Quality Systems Management Review, Product review, Quality Management Committee (i.e. Quality Review Board), Product Discontinuations and Field Actions for the Japan LOC.  Actively partner with various functions within Japan and in Asia Pacific (Japan Leadership Team, Supply Chain, Regulatory Affairs, R&D, Marketing, Sales, Distribution etc.) to meet business objectives.
 
  • Ensure implementation of end-to-end complaints vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS, and track needed actions to address adverse trends.
 
  • Lead preparedness of LOCs for regulatory inspections/audits, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations.
 
  • Keep country management aware of Quality and Compliance related issues/systems through periodic Management Review Process and issue escalation.
 
  • Position will be accountable for designing and implementing successful quality and compliance strategies which will ensure superior Japan customer experience, compliance and the meeting of business goals and objectives.  Position will serve as Sokatsu for Japan Vision.
 
  • Manage and develop a capable organization. Be responsible for budget, staffing, career planning, training & development and providing for a safe & pleasant working environment for all quality employees. Ensure acceptable behavior and performance by the Quality team.
 
  • Position will partner heavily with JJV Franchise Quality including Vision Life Cycle Management organization (such as Product Quality Directors), Regional JJVC and JJVS leadership (including Commercial), Regional Business Quality organizations for J&J, CLS where needed, and the Johnson & Johnson Enterprise quality organization to drive improvements in quality and compliance for Japan. 
 
  • Accountabilities also include all JJV Quality & Regulatory compliance in the region including ensuring successful relationships and communications with MHLW, TMG and other Japan applicable government bodies.
 
  • Position will ensure the Quality Management System (QMS) complies with all external regulatory requirements in accordance with Japan JPAL regulations and associated ISO standards, as well as internal Johnson & Johnson Enterprise and JJV Franchise requirements. 
 
  • Responsibilities also include proactively monitoring, analyzing and improving all aspects of quality compliance, quality control and customer complaint process to drive the Total Customer Experience. Responsible for escalation of relevant issues within the region to the Franchise, facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint process, and all quality assurance components of the QMS in Japan.
 
  • Position will be held accountable for effective and efficient communications to all relevant partners within Japan J&J, especially J&J Vision (Vision Care and Vision Surgical), as well as fostering a QA organizational culture which is high performance, inclusive, collaborative, transparent, and CREDO based.
 
  • Accountable for leading an organization size of approximately 50 to 75 personnel


Qualifications
 
  • 15+ years working experience in technical / quality / regulatory role in the Medical Device Industry.
  • Ability to travel up to 25% required
  • Excellent communications skills mandatory
  • Bilingual in Japanese and English, Oral and Written mandatory
  • Project management skills required
  • Excellent problem solving skills required.
  • Excellent collaboration, interpersonal and organizational skills required.
  • Strong leadership, coaching skills required
  • Demonstrated leadership abilities and proven track record of results
  • Expert understanding of regulatory / compliance requirements for Japan required
  • Experienced with direct communications and interactions with end customer/ user and Japan Health Authorities required
 

Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Johnson & Johnson K.K. (8235)
Job Function
Compliance
Requisition ID
1805625009W