Senior Director, Quality

Summary

Join Foresight Diagnostics, a molecular diagnostics company developing non-invasive cancer detection technologies, as their Senior Director, Quality. This role will create and maintain a quality culture, leading the Quality department in collaboration with other departments to ensure compliance with regulations (CLIA/CAP, US FDA, EU EMA). You will develop and implement quality strategies, oversee quality assurance in the laboratory, establish robust quality standards, and develop risk management strategies. The position requires a Master's or PhD degree in a relevant field, 10+ years of experience (including 3+ years overseeing quality in a CAP-accredited clinical laboratory), and a proven track record of team building and regulatory audit experience. The position offers a competitive salary ($230,000-$250,000), equity, bonuses, and comprehensive benefits.

Requirements

• Master’s degree or PhD degree in an applicable field
• 10+ years of professional experience, with at least 3 years of experience overseeing quality in clinical laboratory with CAP accreditation
• Proven track record of building and developing a team
• Experience leading audits by regulatory bodies
• Demonstrated ability to develop a quality system
• Experience with regulated product development
• Experience as the Quality Management Representative

Responsibilities

• Develop, implement, maintain and continually improve the quality strategy and Quality Management System ensuring compliance with applicable regulations, industry standards, and company policy
• Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technology, and clinical trends and best practices
• In partnership with the Laboratory Director, oversee all aspects of quality assurance and compliance within the laboratory
• Ensure accurate test results and adherence to regulatory standards such as CLIA, CAP, NYDOH, relevant ISO standards such as 15189, 13485, 14971, 62304, the Code of Federal Regulations, and IVDR
• Establish and maintain robust quality standards including quality manual and related standard operating procedures. Ensure these systems are effectively communicated, understood, and followed by relevant stakeholders
• Develop and implement risk management strategies to identify, assess, and mitigate risks associated with clinical patient testing and product development
• Support regulatory inspections, ensure preparedness, and appropriate responses to findings and observations
• Ensure products are developed according to design principles and appropriate regulations
• Developing resourcing and hiring plans for the Quality Team
• Direct management of quality team employees
• Work with site lead to provide leadership and oversight for training programs
• Perform other duties as assigned

Preferred Qualifications

• Experience as the Person Responsible for Compliance under IVDR
• Experience in Regulatory Affairs
• Experience leading cross functional teams to deliver business objectives

Benefits

• Paid vacation
• Sick time
• Parental leave
• Medical
• Dental
• Vision
• Life
• Disability coverage
• Flexible spending accounts
• 401k with company match
• Equity
• Bonus offerings