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.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Clinical Quality and Clinical Compliance Sr. Manager reporting to the Senior Vice President, Regulatory and Clinical Affairs will design and implement risk-based Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit programs and compliance oversight to ensure that Cepheid Clinical Affairs is always in a high-state of inspection readiness. This person will ensure standard operating procedures (SOPs) and clinical templates are compliant with current applicable regulations, laws and guidance for in vitro Diagnostic (IVD) Devices including but not limited to the United States and European markets. This role also provides clinical compliance support for pre-market clinical studies, product labeling, regulatory submission and responses to regulatory agency questions, and scientific publication planning activities.
This position is part of the Clinical Affairs organization and will be a Remote based role.
In this role, you will have the opportunity to:
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.
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.)
Work collaboratively with a wide range of new product development and post-market surveillance stake holder groups.
The essential requirements of the job include:
Expert knowledge of IVD regulatory authority inspection practices internally, externally, domestic and internationally to lead internal and external Clinical Affairs audits/inspections management.
Develop and write new staff training procedures and support materials (manuals), customized for level of staff experience (e.g., CRA, clinical research scientists, biostatisticians and data managers) and provide clinical compliance training to all staff.
Bachelor's degree with 9+ years of experience OR
Master's degree with 7+ years of experience
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
Approximately 10% travel
Cepheid, a Danaher operating 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 danaherbenefitsinfo.com.
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 $105K - $140K. 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. We may ultimately pay more or less than the posted range. 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.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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 (https://www.dol.gov/agencies/ofccp/posters) .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 email@example.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out.
Operating Company: Cepheid