Johnson & Johnson Careers

【Consumer】Source Quality Manager_External Manufacturing

Chiyoda, Japan
Quality Assurance

Job Description

Requisition ID: 1905752770W

Key measures: 

This position will be measured primarily on:

  • Adherence to J&J guidelines and achieving targets set for External Manufactures (EMs).
  • Strategies identification/ implementation for timely, uninterrupted and defect free product supply to the market from the EMs.
  • Compliance to regional/global Strategic Initiatives and proactive closure of gaps within the cluster.
  • Identification, development and retention of critical talent within the team.
Position Description: 

Responsible for overall quality oversight and governance of External Manufacturers and Suppliers. This position will focus on ensuring compliance with applicable regulations, driving and implementing Company’s Quality policies and standards achieving the required business results. The position requires focus on people development and talent attraction/ retention initiatives. The position requires close coordination with business stakeholders such as Supply Chain, Sourcing, Operations, SMP, R&D, Regulatory Affairs, HR and Franchise/SFO organizations to ensure business & compliance goals meets with expected J&J and regulatory standards. 

  • Champion the creation and maintenance of Credo-based environment in his area of responsibility, living Credo values, building trust and caring for people.
  • Provide leadership to achieve Quality & Compliance objectives laid down for External Manufacturers and Suppliers in line with Strategic plans aligned with the Management with customer focus.
  • Ensure the external manufacturing sites assess Quality systems effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate.
  • Support manufacturing sites in the investigation, evaluation and implementation of actions to eliminate root causes of non-conformances.
  • Establish and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business.
  • Provide disposition for non-compliant products and assures escalation of potential quality or compliance problems to regional leader.
  • Ensure effective risk management processes are implemented to prevent unanticipated failure modes.
  • Liaise with the Complaint Vigilance and External manufacturing sites to improve the customer experience through proactive management of complaints. Ensures the manufacturing sites address all customer feedbacks and complaint in appropriate and timely manner.
  • Enable product localizations/New product launches to deliver market appropriate product offerings.
  • Ensure quality processes are followed across the external network by enforcing Quality Agreements, establishing product specifications and deploying quality assurance procedures meeting J&J requirements.  Ensure external partners remains compliant to health authority regulations and other country statutory requirements.
  • Ensure defect free and timely product supply to the market. Establish Governance strategies along with EM make/ source, Procurement, Planning supply chain and Franchise colleagues, to ensure that external partners and sourcing locations continued to remain compliant, agile and flexible to deliver quality products per business needs. Quality events and issues are resolved speedily and through cross functional collaboration as deemed necessary.  
  • Lead people development objectives and support programs to ensure availability of competent people and talent retention. Ensure opportunities and developmental programs are consistently provided to deserving candidates.
  • Support annual budget and BP planning exercise for the cluster managed.
  • Cascade global strategic initiatives and drive deployment of Global standards to the External network for EMs/Suppliers. Ensure adequate gap assessments have been conducted and gaps are closed with definite timelines.
  • Manage the process for reporting key KPIs by collecting, analyzing and summarizing information and trends including improvements expected with External partners and align proactive remediation plans in accordance with business risks.
  • This individual has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product sourced from External Manufactures.

  • At a minimum, a Bachelor’s degree or equivalent in Pharma / Chemistry/Life Science or Engineering.
  • Ten (10) years related experience in Pharmaceutical Industry in Quality Management.
  • About 3-4 years of active management experience including direct supervision.
  • Experience with Japan HA compliance and inspections.
  • Fluency in English-both Written/Verbal.
  • Good Communication and Presentation Skills.
  • Project Management.
  • Business Acumen
  • Systems Development and Integration.

Other Abilities/Qualities

  • Self-directed Working
  • Analytical Thinking and Decision making
  • Influencing, Collaboration and Teaming
  • Self-awareness and Adaptability
  • Talent Development
  • Results and Performance drive
  • Sense of Urgency.

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