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Director, Clinical Quality and Compliance

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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.

For more information, visit .

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here .

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.

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What You Should Know About Director, Clinical Quality and Compliance, Cepheid

At Cepheid, we are on a mission to enhance health care with cutting-edge diagnostic testing, and we're excited to invite a dynamic **Director, Clinical Quality and Compliance** to join our vibrant team in Austin, TX. In this pivotal role, you'll be overseeing the compliance of our Clinical Affairs standard operating procedures with current regulations and laws, ensuring that everything we do meets the highest standards of quality. You will provide clinical compliance support for pre-market studies and lead our robust compliance strategy globally. Your expertise in Good Clinical Practice (GCP) and your experience dealing with regulatory bodies like the FDA will be invaluable as you manage clinical audits and develop strong compliance programs. You'll have a chance to mentor and lead multiple teams while building collaborative relationships with various stakeholders across product development and post-market activities. At Cepheid, we believe in nurturing our associates' growth professionally and personally, which is why we offer flexible remote work arrangements and a supportive environment. If you're passionate about making an impact in health care and have the required qualifications, your contributions could help us solve some of the world's toughest health challenges. We can't wait to see how your experience and enthusiasm will drive our mission forward!

Frequently Asked Questions (FAQs) for Director, Clinical Quality and Compliance Role at Cepheid

What are the key responsibilities of the Director, Clinical Quality and Compliance at Cepheid?

As the **Director, Clinical Quality and Compliance** at Cepheid, you'll be responsible for developing and overseeing a global clinical compliance strategy that aligns with current regulations. You'll handle the internal GCP auditing processes, manage clinical corrective and preventive actions (CAPA), and ensure compliance with necessary standards across Clinical Affairs. Your role will also encompass ensuring the review process for scientific communications and maintaining high standards of compliance across all clinical activities.