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Assoc Dir Global Quality Management

Assoc Dir Global Quality Management

Requisition ID 
2017-9833
Job Locations 
US-NJ-Princeton

Opportunity Details

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

Works in close collaboration with the Head, Global Quality Management and other Global Quality Management Leads to develop and execute the GCP and GVP Global Audit Plans, with their regional resources.

May assume global leadership role for assigned projects. Will support the preparation for and management of regulatory inspections related to GCP and GVP as assigned. In addition, this role will facilitate within North America assigned Global Quality Management operational responsibilities and initiatives, which are inclusive of global SOP Management, CAPA Management, Quality Issue/Serious compliance breach issue support, SOP and Quality related training and Document Management Services. Provide guidance and quality expertise to the business in the interpretation of clinical development regulations, Good Clinical Practice (GCPs) guidelines, Good Pharmacovigilance Practices (GVP), regulatory actions, and other regulatory developments. 

  • Responsible for contributing and executing the Global Audit Strategy and Plan for GCP and GVP activities globally, as assigned. This includes defining risk standards and methodologies, audit methodology and best practises to ensure consistency of approach. 
  • Oversees the conduct of global internal, external, routine and for-cause GCP and GVP audits conducted by auditors (FTE or contracted) from the assigned region 
  • Inclusive of audits in preparation for regulatory inspection
  • Ensures critical issues resulting from audits are identified and escalated 
  • Oversees that the CQM team in the EU region follows the global CAPA process.
  • Supports the establishment and maintenance of Global Quality Management operating procedures, auditing tools, and auditing techniques. Ensures these are being followed by contractors contracted from EU region.
  • Collaborate with other auditors in the Global Quality function in coordinating audit activity in order to maximize efficiencies
  • May serve as an auditor in the execution of the Global Audit Plan
  • Facilitates the conduct of Inspection Readiness and Inspection support activities within the EU region as per applicable SOP and/or Inspection Readiness Plan by:
  • Ensuring collaboration with the business and other auditors in the Global Quality function
  • Ensuring critical issues resulting from inspection activities are identified and escalated 
  • Ensuring all inspection findings and CAPAs are captured and tracked
  • Ensures the CQM team in the EU region is evaluating any regulatory responses in a way that is accurate, acceptable and consistent with the other regions
  • Facilitates the conduct of External Third Party or Partner audits within the EU region by:
    • Ensuring collaboration with the business and other auditors in the Global Quality function
    • Ensuring critical issues resulting from these audits are identified and escalated 
    • Ensuring all audit findings and CAPAs are captured and tracked
    • Oversees that the CQM team in the EU region follows the global CAPA process
  • Facilitates the operational/Process Improvement activities assigned to the regional Subject Matter Experts (SMEs) within the GQM function in the North American region are being managed efficiently and effectively within the established timelines. Ensure that any risks and issues related to GQM operations are to be escalated through the appropriate channels. This will be inclusive of:
    • SOP Management
    • Deviation Management
    • CAPA Management
    • SOP/GCP related Training 
  • Effectively drives process improvements by working with SME’s and Global Quality Management personnel to:
    • Trend quality related issues and engage with the business functions to ensure processes improvements are made
  • Responsible for helping manage the budget/spend related to all Global Quality Management activity in North America 
  • Liaise with other Global Quality functions to ensure consistency of approach and deliver business objectives as requested
  • Member of the GQM Leadership team; ensures that global considerations and activities are communicated locally in responsible region
  • Will attend the Global Quality Leadership team on an ad hoc basis, as required.
  • Collaborates with line managers to ensure that Global Quality Management personnel (employees and contractors) in the EU region are appropriately onboarded (both for the Otsuka company and Global Quality Management department) and trained for their roles.
  • Undertake all line management responsibilities for direct reports.
  • Supports the Head, Global Quality Management in driving innovation and automation for the function
  • May be asked to represent the GQM group as requested if the Head, GQM is unavailable 
  • Any other relevant tasks as directed by the Line Manager or Department Head

Qualifications

Knowledge:

  • Strong knowledge of Good Clinical Practice principles, global regulations regarding clinical development, auditing techniques, document management and government regulatory inspection procedures
  • Good Pharmacovigilance Practices (GVP) experience preferred
  • Open to additional training as deemed applicable (i.e. GVP, Document Management etc.)
  • Strong computer skills of MS Office applications (Word, Excel, PowerPoint Outlook…)
  • Proficiency with TrackWise is preferred
  • Knowledge of applying organizational policy or procedures to a variety of situations
  • Project management experience is preferred  
  • Travel (approximately 30-50%) both domestic and international in nature 

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