Director of Clinical Quality

Director of Clinical Quality Needed For Fast Growing Biopharmaceutical Company

  • San Diego, CA
  • $180,000 - $240,000
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A bit about us:

We are providing a novel biomarker solution to personalize drug development. The core technology of the company is its industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical samples. This technology is especially useful for late stage clinical drugs that have completed trials with unsatisfactory efficacy or side effects.

If you are a Quality Assurance Leader then please read on...

Why join us?

  • Competitive base salary and overall compensation package
  • Full benefits: Medical, Dental, Vision
  • Generous PTO, vacation, sick, and holidays
  • Life Insurance coverage
  • 401 (K) with generous company match

Job Details

Work collaboratively with internal Clinical Operations Team to ensure compliance standards are
  • Manage the GCP Quality interface and support for all Project Teams.
  • Identify and access compliance risk areas and develop and implement risk mitigation measures.
  • Manage GCP audit program to include routine and non-routine quality assurance audits of
clinical investigator sites, vendors, processes, systems and study documents to ensure integrity
and accuracy of study data and assure quality compliance with internal procedures as well as
regulatory guidelines.
  • Review and approve Clinical SOPs.
  • Develop and Implement Clinical QA SOPs.
  • Develop and Implement detailed audit plans and yearly GCP audit schedules.
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Job Details
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Job Type
$180,000 - $240,000