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SR. GVP AUDITOR - San Francisco Bay Area

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Location
CA
Salary
$1 - $1
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Mar 17, 2017
Job ID
2461959
SR. GVP AUDITOR -  San Francisco Bay Area

RESPONSIBILITIES
  • Independently evaluate compliance of logistics and business partners with PV regulations: FDA, EMA, ANVISA and other relevant regulations under International Competent Authorities 
  • Plan, conduct domestic and international GVP audits to assess compliance to local and global government regulations
  • Must be able to work within a global team setting as well as an individual contributor
  • Perform systems audits and due diligence reviews, identify findings and reports findings to management.
  • As a core member of the regulatory compliance inspection team, you will also serve as a subject matter expert leading GVP compliance training and contributing to special GVP projects  
  • Lead, manage and participate, and follow-up on routine on GVP audits.  You will participate in audits of vendors, global sites, partners, affiliates, vendors, internal systems and study reports
  • Lead audit teams in US and abroad, delegate responsibilities to audit team members
  • Lead pre-audit meetings with various departments and gather relevant compliance information
  • Contribute to the development and implementation of Standard Operating Procedures
  • Identify and escalate issues and risks
  • 30% travel domestic and international 
 
EDUCATION
Bachelor's degree
QUALIFICATIONS
  • 12+ years’ experience in relevant GxP role in pharmaceutical/biotechnology industry including minimum 4+ years Compliance and/or audit experience
  • Solid understanding of EMA and ICH Guidelines
  • Experience in international audit and compliance
  • Strong attention to detail
  • Excellent oral and written communication skills
  • Experience in developing, writing and implementing SOPs
  • Certified as an auditor is highly desirable