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GCP/GLP Compliance Manager– Biotech (JP8258)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: GCP/GLP Compliance Manager– Biotech (JP8258)
Location: Thousand Oaks, CA 91320 (Remote until Covid-19 restrictions are lifted)
Employment Type: Contract
Duration: 12 months with likely extension
Business Unit: CRDC - Global R&D Quality
Job posting date: 02/15/2021
 
3 Key Consulting is hiring GC_/GLP Compliance Manager for a consulting engagement with our client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • 5+ years GCP/GLP within pharma or bio tech and bachelor’s degree Minimum
    To provide independent and objective compliance advice and oversight to the business in support of GCP and GLP activities
  • Assess and manage risk, including providing input into the development of the annual audit program
  • Collaborate with other compliance/quality functions to ensure aligned and comprehensive compliance support for R&D & GLP/GCP
  • Participate as compliance representative in evaluating, qualifying and providing oversight of GCP/ GLP vendors
  • Ensure escalation of significant compliance matters to appropriate compliance/quality oversight bodies
  • Prepare, analyze and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information on periodic basis to key stakeholders and senior R&D management
  • Maintain knowledge of current regulatory and compliance practices/issues.
  • Triage and/or manage as appropriate R&D/GLP/GCP compliance matters arising in assigned geographic region.
 
Top Must have Skill Sets:
  • Appropriate compliance background
  • Regulatory inspections - hosting/ managing
  • Direct clinical trial experience (compliance or clinical monitor)
  • Clinical study management experience
  • Good communication skills to partner with internal business partners
  • Ability/ flex to multitask
  • Manage workload and wear multiple hats
 
Employee Value Proposition:
Exposure to R&D network, a lot of regulatory experience due to clinical filing activity
 
Red Flags:
Lack of top 3 must have skills & years of experience, must come from pharma & biotech
 
Interview Process:
Pre-Screen interview followed by Panel interview with staff 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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