About our Company:
Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.
The Opportunity
We are seeking a Senior Director and Head of Quality to lead our Quality function as we advance our colorectal cancer screening test through analytical and clinical validation, FDA premarket approval (PMA), inspection readiness and commercialization. This is a strategic and hands-on leadership role. You will build clear, practical Quality governance and ensure that our QMS and development evidence are complete, connected and ready to withstand FDA review.
Reporting to the COO, you will lead a multidisciplinary Quality organization of 12 people spanning Design Quality, Document Control, Quality Assurance, Quality Systems and Supplier Quality. You will work closely with Product Development, Laboratory Operations, Manufacturing, Clinical, Medical, and Regulatory.
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
• Set and execute the quality strategy, priorities and operating model to support product development, FDA submission, approval and commercialization. Include evaluation and continuous improvement of QMS.
• Ensure a risk-based QMS that meets the FDA Quality Management System Regulation under 21 CFR Part 820, including the incorporated requirements of ISO 13485:2016, and other applicable IVD requirements.
• Lead the quality activities supporting a development program leading to an FDA PMA submission, including design and development controls, risk management, verification and validation, design transfer, manufacturing readiness, submission support and preapproval inspection readiness.
• Lead, coach and organize a quality team of 12 people. Establish clear responsibilities, effective delegation, professional development and succession plans.
• Work cross-functionally to support Product Development, Software, Laboratory Operations, Manufacturing, Clinical, Medical,Regulatory, Legal and other functions in the integration of processes, controls and mandated requirements into development plans, decisions and supporting evidence. Ensure a formal process of impact assessment and change management.
• Provide appropriate quality systems, processes and effective controls are designed into and incorporated across the assay, automation, software and algorithm, laboratory operations, manufacturing and clinical interfaces.
• Design a proactive process of document review and propagation of necessary changes through the documentary corpus that supports the systems, processes and data that will eventually support both the submission and the regulated IVD product.
• Oversee the company's core QMS processes, including document and change control, nonconformance, deviations, CAPA, complaint handling and regulatory-reporting interfaces, supplier quality, training and competence, management review, internal audits, quality objectives and metrics. Including reporting effectiveness to management and ensuring continuous improvement is incorporated into quality activities including cross-functional support and ongoing learning.
• Continuously improve the company’s approach for supplier interfaces and ongoing oversight of suppliers according to a risk-based framework.
• Ensure that the electronic QMS and other regulated electronic records are validated for their intended use and appropriately controlled, including access, workflows, audit trails, data integrity and record retention. Maintain the system in keeping with a risk-based framework.
• Lead audit and inspection readiness incorporating cross-functional SMEs and reporting to management. Prepare and deploy a continuous internal audit model and ensure effectiveness is checked upon implementation.
• Provide senior management with clear, evidence-based information about QMS performance, significant risks, recurring issues, resource needs and readiness for major milestones.
• Promote a culture of quality, accountability and continuous improvement in which employees raise concerns early and establish protected evidence-based escalation and documented preserved challenge.
What you’ll bring
• Bachelor’s degree in life sciences, engineering or a related field; an advanced degree is preferred.
• At least 12 years of progressive \experience in quality within medical devices, IVDs or molecular diagnostics, including at least 5 years leading managers and multidisciplinary quality teams. Prior experience in liquid biopsy, oncology, next generation sequencing-based assays, and algorithm-enabled diagnostics is strongly preferred.
• Direct quality leadership experience with an FDA Class III IVD PMA, or a comparably rigorous high-risk diagnostic program, through major development, analytical and clinical validation, design transfer, manufacturing, regulatory submissions and inspection-readiness milestones. Experience through PMA approval or an FDA preapproval inspection is essential.
• Experience overseeing design controls, requirements traceability, risk management, verification and validation, and development across assays, reagents, instruments, automation, and software.
• Experience with supplier qualification, process validation, equipment qualification, reagent qualification and stability programs, and manufacturing scale up is a strong plus.
• Deep working knowledge of FDA QMSR, FDA IVD and PMA requirements, ISO 13485:2016, ISO 14971, design controls, process validation, supplier controls, CAPA and electronic-record and data-integrity expectations, including 21 CFR Part 11 where applicable.
• Proven ability to scale and maintain a QMS covering document control, employee training, change control, nonconformances, CAPA, supplier audits, and management reviews.
• Demonstrated ability to lead FDA inspections, certification or partner audits, formal responses, remediation and effectiveness verification.
• Experience managing a quality organization, including matrixed teams and multiple quality specialties.
• Strong judgment and communication skills, as well as a practical leadership style: strategic enough to manage and improve the QMS, and hands-on enough to review evidence, coach the team and address important gaps.
• Ability to travel regularly to Dallas and, as needed, to other U.S. or international company, supplier and partner sites.
• Experience with CLIA/CAP laboratories, clinical investigations and GCP, software or machine-learning-enabled devices, and external manufacturers or laboratories is a plus.
What we’ll offer
We’re proud to offer exceptional corporate benefits, which include:
▪ 22 days of PTO with the possibility to carry over 10 days to the following year.
▪ Participation in the Company Equity Incentive Plan.
▪ Company holidays, plus your birthday off.
▪ Company-sponsored benefit plans, including medical, dental and vision insurance; life, short-term disability and long-term disability coverage; and a 401(k).
▪ Flexible work schedule.
▪ And more to come.
Why Now?
This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.
We are looking for passionate changemakers to be a part of our journey in this expansive time for us.