Manager Global Product Quality R&D

US-NJ-Princeton
Requisition ID
2017-9870

Overview

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit   www.otsuka-us.com.   

 

OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

Responsibilities

The Manager or Senior Manager, Global Product Quality, R&D develops, implements and maintains the quality systems and tools required to manage and monitor the quality and compliance of GMP Suppliers that are utilized in the manufacturing, packaging, labeling and testing of OPDC research & development products.  Works with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement.

  • Manages the OPDC GPQ batch record review and release process for research & development products (API, Drug Product and Packaged Final Investigational Medicinal Product/Clinical Trial Material).
  • Leads audits of GMP Suppliers utilized in the manufacturing, packaging, labeling, testing and distribution of research & development products to ensure compliance with local and global requirements as well as applicable regulatory requirements.
  • Reviews and approves quality events, deviations, OOS investigations and change controls.
  • Interfaces with GMP Suppliers and Technical Operations, Technical Services, Clinical Supplies Operations and Quality Control & Analytical Services to drive Quality improvements that minimize the Costs of Quality (specifically component, material or finished product quality events/deviations, OOS investigations, rejects, etc.).
  • Compiles/reviews quality metrics to monitor and improve supplier performance; Provides metric reports and trends to their Manager to help in the preparation of Management reviews and/or other ad hoc reporting requests.
  • Provides support to GPQ Product Quality Complaints Group by ensuring that product quality complaints for research and development projects are investigated by GMP Suppliers/Otsuka internal sites in a timely manner.
  • Negotiates quality agreements with GMP Suppliers. 
  • Author and maintains Standard Operating Procedures, Work Practices and other related documents.
  • Works collaboratively within the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. 
  • Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements.
  • Maintains GMP records (document storage, archiving, retrieval)
  • Travel approximately 30%

* Note: Manager or Senior Manager may or may not have Direct Reports.

Qualifications

Required:

  • Bachelor’s degree in Chemistry, Biology, Engineering or related Science
  • 8-10 years of related experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material or Commercial Product.
  • 5 years of Supplier Quality experience managing/auditing suppliers or equivalent preferred (or experience in internal/external auditing) supporting Investigational Medicinal Product/Clinical Trial Material or Commercial Product.
  • Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional and effective manner.
  • Ability to manage and prioritize multiple tasks
  • Experience in using MS Office (Word, Excel, PowerPoint)
  • Experience in using Trackwise
  • Excellent interpersonal and communication skills 
  • Thorough understanding of GMP requirements and the Drug Development process. 
  • Analytical problem solving and decision making skills.
  • Ability to identify gaps/risks and propose corrective and preventative actions.
  • Position requires approximately 30% domestic travel; Occasional international travel may also be expected.

Preferred:

  • ASQ Certified Quality Auditor certification or equivalent

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