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Clinical Quality Assurance Director

2 months ago

Berkeley, California, United States Bayside Solutions Full time
Job Summary

We are seeking a highly experienced Clinical Quality Assurance Director to lead our quality assurance efforts in clinical trials. As a key member of our team, you will be responsible for ensuring the quality and integrity of our clinical trials, while also driving process improvements and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Develop and implement quality systems and processes to ensure compliance with GCP, GLP, and PV regulations
  • Conduct audits and inspections to ensure quality and compliance
  • Provide training and guidance to clinical teams on quality assurance principles and practices
  • Collaborate with cross-functional teams to ensure alignment and integration of quality assurance activities
  • Develop and implement quality metrics and key performance indicators to measure the effectiveness of quality assurance activities
Requirements and Qualifications
  • 15+ years of experience in clinical quality assurance (GCP, GLP, and PV) in cell and gene therapy/biotechnology or the pharmaceutical industry
  • Subject Matter Expert (SME) working knowledge of current interpretation/implementation of the United States Code of Federal Regulations, ICH Guidelines, and other local government regulatory requirements governing clinical research
  • Proven track record in developing and implementing quality systems and processes in a clinical setting
  • Expertise in creating and executing audit plans outlining all service provider (vendor) audits, clinical investigator site audits, CSV audits, and process audits
  • Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
About Bayside Solutions

Bayside Solutions is a leading provider of clinical research services. We are committed to delivering high-quality services that meet the needs of our clients and their patients. We are seeking a talented and experienced Clinical Quality Assurance Director to join our team and contribute to our mission.