Manager Systems & Supplier Quality

Job Locations US-NJ-Princeton
Requisition ID


A primary function of this role will be to examine the processes across Global Quality pillars and provide innovative solutions and process improvements. An emphasis should be placed on the use of technology to move platforms to a more digital and automated state.


Supports Global Business Operations and Global Product Quality functional leads to manage the Management Review process for the US and Global meetings. This includes coordination of KPIs/Metrics collection across OPC affiliates and subsidiaries and continued development of automated solution to improve the collection and reporting processes.   Supports External and Internal Audit Programs as requested by the Functional Lead. Ability and willingness to learn audit techniques and become a certified auditor in support of these programs


Works with other functional departments within OAPI/OPDC to establish and maintain the effectiveness of Quality Systems to support GxP programs.


The position requires up to 30% travel; mostly domestic and occasional international travel is expected.


  • Support Process Improvement initiatives within department as it relates to Quality Systems, Supplier Quality/Vendor Management and Audits. Introducing innovative ways of managing our processes related to Supplier Quality/Vendor Management Program with development of electronic solution by use of connected databases and systems for Audit Schedule and Approved Supplier List
  • Works collaboratively within the Global Product Quality, GQ Pillars, and other functional areas to ensure compliance to internal standards and regulatory requirements.
  • Compile and report key performance indicators, metrics and compliance status of Quality Systems for Management Review. Provides reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests.
  • Lead and coordinate with Global Factories/Affiliates the gathering and collection of Global KPI/Metrics for the Global Quality Operations office and Global Quality Dashboard for quarterly reporting to Sr. Leadership.
    • Managing Global Metrics Databases and developing innovative processes and tools to manage Metrics. This would include development of global /local database for metrics collection and reporting. Experience in creation, development and management of Metric Databases.
  • Support Supplier Quality lead that all required internal and external audits are planned and scheduled.
  • Support audits of contractors and suppliers to ensure compliance with applicable regulatory requirements.
  • Ensure that audit documentation is accurate, complete, and issued within the required timeframe.
  • Support the review and approve CAPA plans for audit observations. Follow up and management of activities related to correction and CAPA plans for Internal and External Audit observations.

Interfaces with Contractors, Suppliers, Tech Operations, Technical Services and Supply Chain, and Clinical Supply Operations to drive Quality improvements that minimize the Costs of Quality, specifically for component, materials or finished product suppliers

  • Author Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
  • Assists in the development of training programs for inspection readiness and improvements with Internal Audit, Supplier Quality Programs along with other Quality Systems.
  • Participates in Inspection Readiness activities and supports Regulatory Inspections.
  • Interface and support project teams to ensure that the goals set by the team as they relate to potential contractors/ suppliers are consistent with Otsuka quality objectives and relevant governmental requirements.
  • Support TrackWise Enhancements related to Quality Systems, Audit Workflow and Processes.



  • Bachelor’s degree >3 years of experience in pharmaceutical manufacturing and/or medical device industry
  • Working knowledge of FDA 21 CFR Parts 820, 211 and 210 quality system requirements
  • Ability to interact and influence internal and external stakeholders in a tactful, professional and effective manner
  • Ability to manage and prioritize multiple tasks.
  • Technology savvy
  • Excellent interpersonal and communication skills




  • ASQ CQA or equivalent.
  • Experience in using TrackWise, MS Office package


  • Experience in Process Improvement


Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at Learn more about Otsuka in the U.S. at

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