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GCP/GLP Compliance Manager

Thousand Oaks, CA
Top 3 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

Summary

Remote until restrictions are lifted, then required to be on site (ato)
5+ years GCP/GLP within pharma or bio tech
Bachelors 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 
"This posting is for Contingent Worker, not an FTE"

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