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Director, Clinical Quality and Compliance

Cepheid

Miami, FL
1 month ago
$140,600 - $200,300

Job Description

Join Cepheid as the Director of Clinical Quality and Compliance, where you'll lead compliance strategies that enhance global health outcomes. This remote position offers the chance to make a significant impact in diagnostic testing while fostering your career growth.

Key Responsibilities

  • Develop and oversee a global clinical affairs compliance strategy
  • Provide leadership for multiple related teams
  • Ensure SOPs and clinical templates are compliant with regulations
  • Manage compliance review processes for scientific communications
  • Evaluate and implement systems to support Clinical Affairs activities

Required Qualifications

  • Bachelor’s degree in science with 14+ years of clinical quality/GCP experience OR Master’s degree with 12+ years of experience
  • Knowledge of US Good Clinical Practice regulations
  • Proven track record of managing successful clinical audits
  • Ability to build strong relationships with stakeholders
  • 4+ years managing people

Preferred Qualifications

  • Understanding of IVD regulations for Asia, Africa, and Latin America
  • Experience with FDA audit processes

Benefits & Perks

Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay