Associate Director of Clinical Quality Assurance

Published date Posted on Indeed on Aug 17, 2022 (41 d ago)

Piper Companies is currently seeking an Associate Director of Clinical Quality Assurance for a remote opportunity to join a rapidly growing global biopharmaceutical company delivering life-changing therapies to patients with serious and rare diseases.

Responsibilities of the Associate Director of Clinical Quality Assurance

  • Develops, designs, and implements strategic audit plans and SOPs
  • Assures quality and regulatory compliance related to GCPs, pharmacovigilance, GLPs, and other related activities performed by medical and clinical departments
  • Conducts external audits on Investigator Sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports, and writing/reviewing/tracking CAPAs

Qualifications of the Associate Director of Clinical Quality Assurance

  • 5+ years of experience in clinical auditing required
  • Experience with effectively managing regulatory agency inspections is required
  • Full understanding of device regulations, development processes and FDA inspection procedures is required
  • Bachelor’s Degree or higher in biology, chemistry, or related life-sciences discipline

Compensation for the Associate Director of Clinical Quality Assurance

  • Salary Range: $160,000 - $170,000
  • Benefits: Comprehensive; Medical, Dental, Vision, 401k, and open-ended vacation
  • Bonus, stock options, profit sharing
  • This role is remote, but candidates living in the Northeast are preferred

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