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Senior Vice President, Quality, Regulatory & Clinical Affairs
Wondering what’s within Danaher? Take a closer look.
At first glance, you’ll see Danaher’s scale. Our 67,000 associates work across the globe at more than 20 unique operating companies within four platforms—life sciences, diagnostics, water quality, and product identification. Look again and you’ll see the opportunity to build a meaningful career, be creative, and take risks with the support you need to be successful. You’ll find associates who are as certain about their impact as they are about where they’re headed next. You’ll find the Danaher Business System, which makes everything possible. You’ll also see a company that investors trust—our culture of continuous improvement has helped us outperform the S&P 500 by more than 5,000% over the past 25 years.
And no matter where you look at Danaher, at the heart of what we do, you’ll witness our shared purpose—helping realize life’s potential—in action. Whether we’re enabling our customers to provide clean water, supporting a life-saving vaccine development, advancing a new instrument for cancer diagnosis, or ensuring product safety, our work helps improve millions of lives.
We hope you’ll see yourself here, too! What you find at Danaher—and within yourself— might just change the world.
We are seeking a high-performing Senior Vice President, Quality, Regulatory & Clinical Affairs (QRC) leader. The person in this role will consistently link the voice of customers to innovative solutions with a spirit of entrepreneurialism. We are seeking a thought leader who will challenge the status quo and drive the successful launch of new products.
Reporting to the Diagnostics Platform Quality & Regulatory Affairs Leader, the SVP QRC is responsible for leading the activities of Quality Assurance (QA), Regulatory Affairs (RA), and Clinical Affairs (CA) with emphasis on global regulatory and compliance strategies for approval and launch of novel diagnostics products and including those that use machine learning and AI technology to improve clinical outcomes.
Key responsibilities of the role include:
- The SVP, Quality, Regulatory & Clinical Affairs provides strategy and direction to ensure all Quality, Regulatory, and Clinical Affairs systems are established, implemented, and maintained in accordance with applicable standards for BEC and worldwide regulatory requirements. The role is also responsible for ensuring that the business meets or exceeds the expectations of customers and other stakeholders in these areas.
- Ability to partner across the business to ensure new product development and manufacturing processes meet customer expectations and regulatory requirements by executing on a clear regulatory, Clinical and quality strategy aligned to the company’s business strategy & objectives.
- Drive visionary global regulatory strategies for a broad range of IVD diagnostic products with diverse technologies to enable fast market access based on solid understanding of the regulatory landscape and keen business acumen.
- Represent company interests with national government agencies, industry associations, and/or other organizations in all regions for the purpose of collaboration on policy changes, standard setting and ensuring compliance with legislation, regulations and/or guidelines that impact the business in the clinical diagnostic market.
- Lead the global RA team to provide best-in-class regulatory strategy as well as rigorous execution to enable rapid market authorization & commercialization across the globe
- Oversight of Global Clinical Affairs team responsible for translating global market needs and regulatory requirements into successful clinical evidence strategy, which includes clinical trial strategy, trial design, Biostatistics and Data Management, Clinical Compliance and execution to ensure market access and product lifecycle sustainment).
- Build and develop a high-performing organization aligned to support key business priorities spanning in vitro diagnostics.
- Foster and maintain strong relationships with senior QA, RA & CA leaders across DHR and leverage best practices and opportunities to drive cross-business collaborations and initiatives.
The successful candidate will:
- Leadership: Demonstrated success in effectively leading a quality, regulatory & clinical organization, including a history of building a cohesive organization working collaboratively across all parts of the organization.
- Collaboration/relationship building: The successful candidate will be assertive, poised, and professional and have demonstrated the ability to build bridges and influence upward. He/she will be someone who builds trust through consistency and a high level of integrity.
- Demonstrate Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure. Challenges the status quo. Takes stands to resolve important issues. Energized by tough challenges. Is comfortable with change.
- Lead by Example: Possess demonstrable leadership skills; has the ability to move others to action, including peers, superiors and subordinates. Demonstrate a positive, results-oriented style. Able to develop others, and manage performance of team through coaching and feedback, willing/able to share personal knowledge and experience with others.
- Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings.
- Continuous Improvement: Recognized leadership in developing and managing a continuous improvement culture.
- Willing and able to travel as required
Education and qualifications include:
- Bachelor’s degree with 20+ years of experience; 6+ years of executive leadership experience, managing diverse, geographically dispersed teams
- Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
- Subject matter expertise in Quality & Regulatory experience working with the FDA in the medical device, diagnostics, or pharmaceutical industries. In depth knowledge of regulatory requirements, in vitro diagnostics a plus
- Broad cultural orientation, experience of working in an international environment and exposure to doing business globally.
- Demonstrated track record of developing organization capability.
- Possess a broad knowledge of surrounding areas including Manufacturing and Development
- Demonstrated track record of successfully influencing a company’s most important strategic decisions to value-building outcomes and launching products with excellence
At Danaher, we’re driven by a sense of wonder for what we can create—and what we can become. Here, you’ll accelerate your career while driving innovation that improves lives! You’ll work hard and take risks, with guidance from committed leaders, powerful DBS tools, and the support of a global organization.
If you’d like to learn more, read stories from our associates on our Careers Blog or reach out to one of our recruiters.
The company’s Diagnostics segment offers analytical instruments, reagents, consumables, software and services that hospitals, physicians’ offices, reference laboratories and other critical care settings use to diagnose disease and make treatment decisions. Sales in 2019 for this segment by geographic destination (as a percentage of total 2019 sales of $6.6 billion) were: North America, 39%; Western Europe, 17%; other developed markets, 6% and high-growth markets, 38%. Danaher established the Diagnostics business in 2004 through the acquisition of Radiometer and expanded the business through numerous subsequent acquisitions, including the acquisitions of Vision Systems in 2006, Genetix in 2009, Beckman Coulter in 2011, Iris International and Aperio Technologies in 2012, HemoCue in 2013, Devicor Medical Products in 2014, the clinical microbiology business of Siemens Healthcare Diagnostics in 2015 and Cepheid in 2016.
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 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.
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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 firstname.lastname@example.org to request accommodation.
If you’ve ever wondered what’s within you, there’s no better time to find out.
Job posted: 2023-05-24