The Opportunity:

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

We are seeking an experienced and strategic Senior Director of Clinical Quality to lead our clinical quality assurance and improvement initiatives. This home-based role will oversee the development, implementation, and monitoring of quality programs to ensure compliance with regulatory standards, enhance clinical performance, and drive excellence in diagnostic services. The ideal candidate is a visionary leader with a deep understanding of clinical quality systems, regulatory requirements, and process improvement in the diagnostic industry.

What you’ll bring:

· Develop and implement comprehensive clinical quality assurance and improvement programs to ensure compliance with federal, state, and industry standards (e.g., CLIA, CAP, FDA, CMS).

· Oversee quality metrics, audits, and performance improvement initiatives to maintain high standards of diagnostic accuracy, reliability, and patient safety.

· Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and R&D, to integrate quality standards into all aspects of diagnostic processes.

· Monitor and analyze clinical quality data, identifying trends and implementing corrective actions to address gaps or non-compliance.

· Lead the preparation for and response to regulatory inspections and accreditations, ensuring all documentation and processes meet required standards.

· Develop and deliver training programs to educate staff on quality standards, best practices, and regulatory requirements.

· Stay current on industry trends, regulatory changes, and advancements in diagnostic technologies to inform quality strategies.

· Foster a culture of continuous improvement, promoting proactive solutions to enhance clinical outcomes and operational efficiency.

· Prepare and present quality reports to senior leadership, providing actionable insights and recommendations.

· Manage a remote team of quality professionals (if applicable), ensuring alignment with company goals and quality objectives.

Qualifications and Requirements

· Bachelor’s degree in a relevant field (e.g., Clinical Laboratory Science, Healthcare Administration, Nursing, or related); advanced degree (Master’s, PhD, or equivalent) preferred.

· 7+ years of experience in clinical quality assurance, quality management, or a related role in the diagnostic or healthcare industry.

· Proven expertise in regulatory compliance (e.g., CLIA, CAP, FDA, ISO 15189) and quality management systems (e.g., Six Sigma, Lean).

· Strong analytical skills with experience in data-driven decision-making and performance improvement methodologies.

· Excellent leadership and communication skills, with the ability to collaborate effectively in a remote work environment.

· Proficiency in quality management software, data analysis tools, and Microsoft Office Suite.

· Ability to work independently, manage multiple priorities, and thrive in a fast-paced, home-based setting.

· Certification in quality management (e.g., CQA, CQM, or similar) is a plus.

Preferred Qualifications

- Experience in start-up or small biotech environments.

- Certification in clinical research (e.g., CCRP or ACRP).

- Familiarity with diagnostic-specific regulations (e.g., CLIA, CAP).