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Job Description
Join Cepheid as the Director of Clinical Quality and Compliance, where you will lead compliance strategy and ensure adherence to regulatory standards in clinical affairs. This remote role offers the chance to significantly impact global health through innovative diagnostic solutions.
Key Responsibilities
Develop and oversee the design and execution of a global clinical affairs compliance strategy
Provide leadership to managers and professional associates
Ensure compliance with internal GCP auditing and clinical CAPA management
Maintain Clinical Affairs department SOPs and clinical templates
Manage compliance review process 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 within the device industry OR Master’s degree in science with 12+ years of clinical quality/GCP experience within the device industry
Knowledge of US requirements and regulations related to Good Clinical Practice
Proven track record of managing successful clinical audits
Ability to build strong relationships and trust with global internal and external stakeholders
4+ years managing people
Preferred Qualifications
Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America)
FDA audit (e.g., BIMO) process
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay