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


Keywords
: associate director, clinical, clinical quality assurance, quality assurance, AD, QA, phase I, phase II, phase III, TPIP, Treprostinil Palmitil Inhalation Powder, CQA, certified quality auditor, pharmaceutical, pharma, biopharmaceutical, life science, initiation, audit, rare diseases, SOP, database management, IRT audits, interactive response technology audits, TMF, trial master file, site audits, quality review, clinical research organization, CRO, sponsor, GCP, good clinical practice, pharmacovigilance, GLP, good laboratory practice, GVP, good pharmacovigilance practice, ICH E6, Veeva QMS, Vault


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