<div><img src="https://mc.yandex.ru/watch/71228401" style="position:absolute; left:-9999px;" alt="" /></div>
Use AI search

Senior Director, Global QRC Strategy and Project Management

Cepheid

Apply now

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 which makes everything possible.

The Senior Director, Global QRC Strategy and Project Management will work closely with QRC (Quality, Regulatory Affairs and Clinical Affairs) leadership and cross functions.  Reporting directly to our SVP, Global Quality Regulatory and Clinical Affairs, this highly impactful role will focus on the strategy, planning and execution of our QRC initiatives and projects; be a liaison for new product knowledge acquisition and innovation pipeline; be a senior staff member providing strategic advice and consultation to QRC leadership team.  This role will be responsible for the vision, plan and competitive advantage of our future global QRC capability while ensuring support for both immediate and long-term QRC functional and organizational growth through sophisticated coordination and communication skills.   

This position is part of the Global Quality Regulatory and Clinical Affairs and can be located in Sunnyvale, California or remote.

In this role, you will have the opportunity to:

  • Analyze and help outline the path of key QRC initiatives from development through successful execution under the guidance of QRC leadership.

  • Oversee the translation of the QRC Strategy into business plans, including scenarios and key questions, in order to develop the appropriate initiatives to support it.

  • Activate executive leadership to foster change through accountability, alignment, engagement, and visibility.

  • Provide strong thought leadership: guiding and challenging stakeholders and project team members, providing decision support and analysis, sharing best practices, ensuring consistency of approach, managing cross-functionally and any other interdependencies, and resolving roadblocks.

  • Develop and communicate QRC Competitive Advantage/Transformation/Project Plan: targets, timelines, milestones, KPIs, change management, communication, and execution approach.

  • Serve as liaison between QRC staff and other senior leaders regarding critical identified projects, including but not limited to digital data management, innovation pipeline, NPD knowledge acquisition, global regulatory council, Danaher platform QRC initiatives, for the business.

  • Serve as a QRC transformation and strategy subject matter expert for the team and develop action plans with the QRC leaders to address them.

The essential requirements of the job include:

  • Bachelor's Degree in Engineering, Biology, Biochemistry, or related scientific field with 14 years of Medical Device industry experience OR Master’s degree in field with 12+ years of Medical Device industry experience.  A minimum of 4 years of leadership experience in managing both processes and resources.

  • Expert knowledge of US FDA and ISO requirements.

  • Quality Regulatory and Clinical professional credential and expertise.

  • The ability to develop strategic goals and objectives from knowledge base and understanding of a customer’s business.

  • Manage changing conditions, processes and approaches; lead organizations through change effectively.

  • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.

  • Track record of measurable, operational improvements to QRC related functions.

It would be a plus if you also possess previous experience in:

  • Experience with PMO and QRC operations and management with nimble business mind and excellent communication skills. 

  • Training and certificates in quality, regulatory affairs or Process Excellence (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles).

  • Experience with molecular diagnostics or IVD industry in managing both processes and resources.
     

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 danaherbenefitsinfo.com.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 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.

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 202.419.7762 or applyassistance@danaher.com to request accommodation.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Senior Director, Global QRC Strategy and Project Management

Cepheid

Apply now