Spencer Rigby · 5 hours ago
Director of Quality
United States
Full-time
Remote
Director/Executive
10+ years expSpencer Rigby is a rapidly emerging liquid biopsy and early cancer detection company seeking a Director of Quality to define, build, and scale its global quality strategy. The role involves leading the company’s quality management strategy across various functions to ensure compliance with global quality standards while supporting innovation and product commercialization.
Staffing & Recruiting
Hiring Manager
Kyle McMahon
Responsibilities
Develop and execute a comprehensive quality strategy aligned with the company’s commercial, clinical, and scientific objectives
Lead and maintain the Quality Management System (QMS) to ensure compliance with applicable regulations and standards (e.g., CLIA, CAP, FDA, ISO)
Drive quality oversight across product development, design controls, validation, manufacturing, and laboratory operations
Partner cross-functionally with R&D, Clinical, Regulatory, Operations, and Commercial teams to embed quality throughout the product lifecycle
Lead internal and external audits, inspections, and regulatory submissions from a quality perspective
Establish and monitor quality metrics, KPIs, and continuous improvement initiatives across the organisation
Oversee supplier quality management, including qualification, monitoring, and performance management
Ensure effective CAPA, deviation, complaint handling, and risk management processes are in place and operating effectively
Support new product introductions, scale-up activities, and global market expansion from a quality and compliance standpoint
Build, lead, and mentor a high-performing quality team as the organisation grows
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or MBA) preferred
Minimum of 10 years of progressive experience in Quality within biotech, diagnostics, or life sciences, with leadership experience preferred
Strong working knowledge of regulatory and quality frameworks including FDA QSR, ISO 13485, CLIA, and CAP requirements
Proven experience supporting regulated product development and commercial launch within molecular diagnostics or oncology
Experience leading audits, regulatory inspections, and quality system implementations or transformations
Strong understanding of risk management, design controls, validation, and lifecycle quality processes
Excellent communication, stakeholder management, and cross-functional leadership skills
Ability to operate strategically while maintaining strong operational execution in fast-paced, growth-oriented environments
Preferred
advanced degree (MS, PhD, or MBA)
leadership experience
Company
Spencer Rigby
Spencer Rigby is a specialist Recruitment Consultancy in the Med Tech & Life Science sectors.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase