Sr. Manager, GCP

San Francisco  ‐ Onsite
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Description

Requirements and Responsibilities:


  • Minimum of 8 to 10+ years' experience in the pharmaceutical/biotechnology industry.


  • Assist with development of the audit strategy and programs.


  • Accomplished knowledge of global and local GCP regulations.


  • Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP
  • Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
  • Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards


  • Clinical Quality System and Clinical computerized systems; e.g., EDC, IxRS, etc.
  • Provides oversight and directs training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing..
  • Identify/monitor GCP compliance risks;provide guidance on mitigation/management of such risks.
  • Lead and/or support GCP inspection readiness and inspection management activities.
  • Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams.
  • In collaboration with the Director, CQA, ensure that appropriate Standard Operating Procedures are in place
  • Appropriately and expeditiously escalate GCP compliance issues.
  • Communicate audit results to management and auditees through written audit reports.
  • Assist with training/orientation/qualification of new CQAAuditing staff
  • Travel required up to 35% as needed (travel may be domestic and international)


To find out more about Real please visit www.realstaffing.com
Start date
08/2013
From
Real Staffing
Published at
03.08.2013
Project ID:
577421
Contract type
Permanent
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