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Senior Quality Lead – FSP

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Brazil

Posted

65 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Quality Lead – FSP

Parexel

• Identify, evaluate and respond to GCP quality risks related to vendor and site engagement • Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings • Provide quality oversight reports to appropriate sponsor's management / functions • Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties • Validate, monitor and close out GCP-quality-related action plans • Evaluates quality performance at an enterprise level to inform continuous improvement of quality risk management • Informs site organization relationship owner of quality improvement considerations • Support QMS09 BPO in the development and implementation of process updates • Support Vendor Leads / Business Owners to ensure compliance with functional level vendor oversight requirements

Job Requirements

  • BS--7+ years or equivalent
  • MS/MBA – 6+ years or equivalent
  • Minimum of 5 years of pharmaceutical experience with solid experience in clinical trial development.
  • Robust knowledge in quality areas (i.e. audit, inspection, compliance, and inspection readiness fields)
  • Quality related experience including working knowledge in:
  • o Quality and compliance management, QC
  • o Root Cause Analysis
  • o Risk identification, controls, mitigations, and actions
  • o Metrics development and utilization
  • o Audit and Inspection conduct and CAPA response process
  • Ability to develop strategies using coordinated and transparent metrics to track and manage compliance
  • Ability to participate in cross-line global initiatives or root cause analysis for quality related process improvement.

Benefits

  • Health insurance
  • Flexible working arrangements
  • Professional development opportunities

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