Manager Quality Auditor (GCP)

US-Remote
Requisition ID
2017-9922

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 Senior Quality Specialist level is considered to be a position of increased responsibility within the Global Quality Management function. In this role, the Sr. Quality Specialist will be responsible for the GCP and/or GVP auditing internal and external entities. In addition, this role will represent CQM as a member of a Study Team and/or Otsuka and Global Quality initiatives, independently providing GCP guidance while supporting Inspection Readiness visits.


This role may also support Quality operations within the Global Quality Management group; potentially as a Subject Matter Expert (SME), 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.

  • Independently preparing for conducting and authoring reports for routine and directed clinical investigator site audits, External Service Provider audits (CRO audits, SMO audits, Vendors), internal process audits 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.
  • 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 goals and objectives

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 

Job Requirements

  • Travel (approximately 30-50%) both domestic and international in nature 

Education & Related Experience

  • 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 
  • Advanced degree(s) preferred

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