Johnson & Johnson Careers

【Consumer】Source Quality Manager

Chiyoda, Japan
Quality (Generalist)

Job Description

Requisition ID: 1700205566W

<Scope of the role:>
  • Execute overall Quality &Compliance mission, vision and yearly target for the External Manufacturing, Raw and Packaging Material Suppliers in the network.
  • Interdependent partnership with Regional Q&C and other affiliates.
  • Responsible for all Source quality decision related to External Manufacturing sites in Japan and its remediation activities.
  • Close collaboration with R&D, Supported Market Products, Technical Transfer, Global Packaging, Regulatory, Supply Chain, Customer Logistics and Service, External Manufacturing Make. 
  • Support compliance to Regulatory authority, Enterprise and Sector Quality & Compliance requirements for External Manufacturing, Suppliers.
  • Establish, implement and maintain robust Quality System of External Manufacturing and Suppliers, particularly on Internal Audits,
  • Audit-Readiness, INV/CAPA and Change Control effectiveness.
  • Support achievement of goals in GOC metrics.
  • Ensure robust micro risk prevention activities in External Manufacturing.
  • Ensure timely and comprehensive investigations of quality issues, including manufacturing complaints, at External Manufacturing and Suppliers.
<Key measures : The position will be measured primarily on:>
  • Meeting set goals on GOC Metrics
  • Compliance to Regulatory Authority requirements, Enterprise policies and standards, Regional and Local procedures.
  • Zero critical observations in J&J Regulatory Compliance assessments, on-time completion of audit actions, mitigations and commitments
  • Acceptable Ratings of External Manufacturing and Suppliers.
  • No delays /issues in new product launches and other initiatives (e.g. NPI/NPD, promos) due to quality at External Manufacturing and Suppliers
  • Development of quality mind-set of External Manufacturing and Suppliers, e.g. Zero Defect commitments where applicable 

<Required Competencies and Skills: >
  • Leadership, collaboration and interpersonal skills.
  • Sufficient knowledge of local regulations, cGMPs, Policies, Enterprise Standards, WWSP’s, QSP’s and other Quality Systems and Guidelines.
  • Results oriented and able to independently create and deliver
  • Self-starter / entrepreneurial
  • Strategic thinking
  • Analytical and process-oriented
  • Sufficient knowledge on manufacturing processes
  • Good communication and presentation skills
  • Decision making and problem solving
  • Commands respect both in personal and in the areas of expertise and responsibilities
<Qualification & Experience >
  • Educational Qualification: Pharmacy, Science or Chemical Engineering Graduate/Post Graduate/Doctorate
  • Computer skills with MS Office knowledge – word, excel, powerpoint etc.
  • 10-15 years experience in Pharmaceutical, Cosmetics or food industry

Primary Location
Johnson & Johnson K.K. (8235)
Job Function
Quality (Generalist)
Requisition ID