At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
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The Senior Manager, Clinical Quality and Compliance reporting to the Senior Director of Clinical Compliance will ensure that Danaher Diagnostics Clinical Center of Excellence standard operating procedures (SOPs) are compliant with current applicable regulations, laws and guidance including but not limited to the United States and Europe. This role also provides clinical compliance support for pre-market clinical studies.
This position is part of the Clinical Affairs organization and will be a Remote-US based role.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• 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 with hands on experience in dealing directly with FDA and other regulatory agencies
• Proven track record of managing successful clinical audits and define/support non-conformances and CAPA
• Ability to build strong relationships and trust with global internal and external stakeholders
• 4+ years managing people

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America)
• FDA audit (e.g., BIMO) process

• Refine, expand and oversee the design, build and execution of a robust and global clinical affairs compliance strategy and program including internal GCP auditing (i.e., TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR compliance across Clinical Affairs.
• Provide leadership to managers and professional associates and is accountable for the performance and results of multiple related teams.
• Apply thorough knowledge of current international requirements of GCP, GLP, FDA, ICH, EU, and applicable global regulations to ensure all Clinical Affairs department standard operating procedures (SOPs) and clinical templates are maintained in a high state of compliance.
• Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by the Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals.
• Evaluationof systems used to support Clinical Affairs activities. (i.e., CTMS, Smartsheets, etc.) and to ensure compliance with applicable international and national standards, regulations, and guidelines (i.e., 21CRF Part 11, etc.)
• Influence managers and leaders on subjects related to compliance, while working collaboratively with a wide range of new product development and post-market surveillance stakeholder groups.