Manager Auditor Clinical Quality Management

US-NJ-Princeton
Requisition ID
2017-9846

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, Global Quality Management level is considered to be a position of increased responsibility within the Global Quality Management function. This role will be responsible for the GCP and/or GVP auditing internal and external entities as per the Global Audit Program.


In addition, this role may represent GQM as a member of a Clinical project team and/or Otsuka and Global Quality initiative teams.


This role may also support Quality operations within the Global Quality Management group. who will be responsible for driving the management of assigned activities within the group. This could include SOP Management, CAPA Management, Deviation Management, SOP/GxP related Training and Inspection Readiness and support in addition to other assigned Quality tasks.

 

  • Manage processes and activities within the GQM group as assigned; may act as an SME for a system or a process
  • Serve as line-manager for contingent workers responsible for GQM activities 
  • Responsible for the preparation, conduct and reporting for routine and directed clinical investigator site, Vendor, Partner, Pre-Qualification, internal and external partner and both domestic and international as assigned 
  • Independently or within a committee reviews and determines acceptability of CAPAs 
  • Drives or participates in the optimization and/or execution of assigned GQM operational responsibilities
  • May be responsible for oversight of Document Management 
  • Prepares and delivers internal and external presentations, as assigned 
  • Working with CQM colleagues, assists in the follow-up and escalation process for Corrective Actions Preventive Actions (CAPA) identified via the audit process
  • Serves as a subject-matter expert in the Deviation process; supports the business in documenting and closing deviations 
  • Independently provides GCP guidance and shares expertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines
  • Inspection Readiness activities and regulatory authority inspection and/or external audit support
  • Properly escalates issues and risks to the Otsuka business to GQM Leadership 
  • Acts as a Global Quality liaison to one or more Otsuka business functions and/or project teams
  • Performs activities that support overall departmental and business goals and objectives
  • Exhibits significant competencies related to all GQM systems and procedures
  • Serve as Mentor for new staff when requested

Travel (approximately 30-40%) 

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, CSV etc.)
  • Strong computer skills of MS Office applications and SharePoint (Word, Excel, PowerPoint Outlook…)
  • Proficiency with TrackWise is preferred
  • Knowledge of applying organizational policy or procedures to a variety of situations
  • Self-driven, comfortable supporting others, innovative
  • Project management experience is preferred 
  • Travel (approximately 30-50%) both domestic and international in nature 

Education:

  • Bachelor's degree in life science and 8 plus years of experience in regulated worldwide clinical drug, biologic or device development
  • More than 4 years of GCP and/or GVP auditing and/or Quality management experience preferred 

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