Director of Quality Assurance and Regulatory Affairs

4 weeks ago


San Diego, California, United States Inocras Inc Full time
Job Title: Director of Quality Assurance and Regulatory Affairs

We are seeking a highly experienced and skilled Director of Quality Assurance and Regulatory Affairs to join our team at Inocras Inc. This is a critical role that will be responsible for building and maintaining quality systems for our next-generation sequencing clinical laboratory.

Key Responsibilities:

  • Develop, implement, and maintain quality and regulatory programs and strategies to ensure compliance with global market requirements.
  • Partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets.
  • Oversee the performance of internal and external audits, including ISO 15189, ISO 27001, State of California, CAP, and CLIA.
  • Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, NCMRs, Deviations, and Complaints.
  • Develop and implement innovative programs to focus employees on improving product quality.

Requirements:

  • Minimum of 10 years of experience in quality assurance and regulatory affairs, preferably in the medical, healthcare, or Biotech sector.
  • Extensive experience hosting regulatory inspections and interacting with regulators.
  • Expertise in CAP, CLIA, GLP, cGDP, FDA, ISO, State of California, CLEP, and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
  • Strong leadership and team management skills.
  • Excellent communication, negotiation, and problem-solving abilities.

About Inocras Inc.

Inocras Inc. is a precision medicine whole genome platform company with the goal to accelerate the use of whole genome sequencing (WGS) for accurate diagnosis and personalized treatment for cancer and rare diseases. Our proprietary platform is an automated WGS pipeline coupled with a bioinformatics-powered digital solution that rapidly generates meaningful medical insights making it possible to use WGS in real-life clinical settings.

Benefits:

  • Health, Dental, Vision, and employer-covered AD&D policy.
  • 401k plan.
  • Paid Holidays, Sick, and PTO.

Compensation:

$175,000 - $185,000 annual salary BOE.



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