Director, Clinical Quality and Compliance

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 Director, Clinical Quality and Compliance reporting to the Sr Director of Clinical Research or VP of Clinical Affairs will ensure that Cepheid Clinical Affairs 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. In this role, you will have the opportunity to:

• Develops 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.
• Provides 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, CE, 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.
• Evaluation, acquisition, and implementation of systems 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.)
• Persuade managers and leaders, while working collaboratively with a wide range of new product development and post-market surveillance stakeholder groups.

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

Physical Demands:

• Must be able to travel approximately 10%

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at .

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide. The salary range for this role is $140,600-200,300. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.