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GCP Compliance Manager

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
                                                            
Top 3 Must Have Skills
  • Experience with risk management
  • Compliance management experience
  • Regulatory audit and inspection experience
  • Cross functional interaction experience
  • Therapeutic knowledge is highly preferred but not required

Day to Day Responsibilities:
  • Assess and manage risk, including providing input into the development of the annual audit program
  • Collaborate with other Amgen compliance/quality functions to ensure aligned and comprehensive compliance support for R&D & GCP
  • Participate as compliance representative in evaluating, qualifying and providing oversight of GCP 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/GCP compliance matters arising in assigned geographic region


"This posting is for Contingent Worker, not an FTE"

 

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