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Director of Quality Assurance

  • Job type: Permanent
  • Location: New Jersey
  • Salary: $160000 - $200000 per annum
  • Job reference: ARTR022318544
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 23/02/2018
Director of Quality Assurance
  • Biotech
  • New Jersey
  • Competitive Salary + Excellent Benefits + Excellent Career Growth Opportunities
A clinical stage oncology-focused biotech company is seeking a Director of Quality Assurance as their team is rapidly expanding! This company has 6 indications in various stages of clinical trials with 2 indications on track to be approved by the FDA later this year. Now is a critical time to get with this organization as you will have the ability to impact the direction of the company as their new drugs get approved.

Director of Quality Assurance will be responsible for the following duties:
  • Develop, implement, and execute the audit strategy and plan for clinical program
  • Partner with Clinical Study teams to ensure studies are compliant with applicable regulatory requirements through operational activities and training
  • Implement, communicate, and monitor Intra-Cellular Therapies Quality, GCP compliance audit and inspection readiness approach to clinical study teams and key stakeholders
  • Contribute in developing and creating the Clinical QA infrastructure and strategic direction
  • Train/coach Clinical QA and/or other QA personnel in preparing, conducting, and reporting GCP audits of investigational sites, Service Providers, CROs, and other types of audit as assigned
  • Execute the Clinical QA, GCP Compliance Audit and Inspection Readiness strategic goals and objectives
  • Help develop and maintain SOPs for clinical development activities
  • Help develop and maintain training records for personnel involved in activities related to clinical development.
Director of Quality Assurance will have the minimum requirements:
  • 8+ years of pharmaceutical (or related field) experience
  • 4+ years clinical quality assurance experience
  • 2+ years management experience
  • GCP experience is required
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