Senior Manager/Associate Director, Quality

About the Company

At Countable Labs, we’re reimagining the future of genomics. As the innovators behind our groundbreaking Countable PCR platform, we’re building tools that make a real impact in precision medicine. We’re a fast-growing startup fueled by innovation, collaboration, and a mission-driven spirit.

Responsibilities

• Build and own the quality management system (QMS) from the ground up, including document control, training, and design control procedures
• Design and implement end-to-end complaint handling, CAPA, and change control processes
• Lead qualification and quality management of the supplier and CDMO network
• Oversee incoming inspection, in-process controls, and final product release
• Guide core teams on design control activities, including verification, validation, and design reviews
• Lead risk management activities such as FMEA and hazard analysis
• Lead design transfer activities to ensure manufacturing readiness

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, or a related field
• 7+ years of progressive experience in quality
• 3+ years in a leadership or people management role within biotech, life sciences, or diagnostics
• Proven track record of owning design control and product development quality (DHF management)
• Experience managing supplier quality and CDMO relationships
• Deep expertise in quality systems (SOPs, change control, CAPA)
• Strong command of risk management principles (FMEA, hazard analysis)

Preferred Qualifications

• Working knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, or CE IVD frameworks
• Experience scaling quality systems from RUO to IVD or regulated product development
• Exposure to instrumentation, software, or reagent-based products