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Job Description
Join Cepheid as the Director of Clinical Quality and Compliance, where you'll lead the development of a global compliance strategy to ensure adherence to clinical regulations. This remote role allows you to make a significant impact on healthcare diagnostics while fostering career growth within a collaborative environment.
Key Responsibilities
Develop and oversee a global clinical affairs compliance strategy and program
Provide leadership to managers and professional associates
Ensure compliance of Clinical Affairs department SOPs and templates
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 within the device industry OR Master’s degree with 12+ years of experience
Knowledge of US regulations related to Good Clinical Practice
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 other geographies (e.g., Asia, Africa, Latin America)
Experience with FDA audit processes
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay