Senior Manager/Associate Director, Quality

Senior Manager / Associate Director, Quality

At Countable Labs, we're reimagining the future of genomicsand we'd love for you to be a part of it! 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. If you're ready to roll up your sleeves, build something from the ground up, and help shape the future of genomics, we want you on our team!

We are seeking a Senior Manager / Associate Director of Quality to own and execute the quality and compliance function of our organization as we scale from development into early manufacturing into commercialization. This is a full-time position. This is a hands-on, execution-focused leadership role responsible for building and owning Countable Labs' quality function. You will partner directly with R&D, engineering, manufacturing, and external partners (CDMOs and suppliers) to set quality strategy, drive execution, and establish the systems and culture needed for long-term regulatory readiness. While our current products are RUO, this leader will architect the quality infrastructure to support future IVD and regulated product pathways.

Quality Systems Support

• Build and own the quality management system (QMS) from the ground up, including document control, training, audit readiness, and design control procedures.
• Design and implement end-to-end complaint handling procedures, including intake, investigation, trending, and response.
• Own and govern document control, change control, and CAPA processes, ensuring consistent compliance across the organization.
• Define, track, and report on quality KPIs (e.g., internal and external defects, CAPA cycle time) to senior leadership; drive data-informed decisions for continuous improvement.
• Establish and oversee training programs and compliance requirements across all departments, ensuring readiness for internal and external audits.
• Implement and maintain robust quality event tracking systems to enable visibility, accountability, and proactive risk management across the organization.
• Lead post-market surveillance strategy, including feedback loop design, performance monitoring, and signal detection to inform continuous improvement and future regulatory submissions.

Contract Manufacturing Organization (CDMO) & Supplier Quality

• Lead qualification and ongoing quality management of the supplier and CDMO network, establishing a scalable supplier quality program.
• Direct supplier evaluations, audits, and performance monitoring; define risk-based selection criteria and corrective action expectations.
• Oversee review and disposition of supplier documentation including CoAs, deviations, and change notifications; establish escalation protocols and approval workflows.
• Define and enforce quality requirements through specifications, quality agreements, and supplier contracts; serve as the primary quality interface with external manufacturing partners.

Manufacturing & Quality Support

• Own the strategy and oversight of incoming inspection, in-process controls, and final product release, ensuring processes are scalable as manufacturing volume grows.
• Define and own product specifications and acceptance criteria in partnership with R&D and engineering; ensure documentation reflects current product state and regulatory intent.
• Lead investigations across nonconformances, deviations, and complaints; drive root cause analysis and ensure timely, effective corrective and preventive actions with appropriate escalation to leadership.
• Establish documentation and traceability standards for all builds and testing activities, ensuring audit-ready records at every stage of the product lifecycle.
• Drive resolution of supplier-related quality issues across cross-functional teams; own supplier corrective action requests (SCARs) and ensure timely closure.

Product Design & Development Quality

• Guide core teams on design control activities, including design inputs/outputs, verification, validation, and design reviews; serve as the quality authority in all product development gate decisions.
• Partner closely with R&D and engineering as a quality leader, ensuring requirements, specifications, and test plans are clearly defined, documented, and aligned with regulatory strategy from the start.
• Own approval and governance of development documentation (protocols, reports, design history file (DHF) content), maintaining a complete and inspection-ready DHF throughout the product lifecycle.
• Lead risk management activities (e.g., FMEA, risk assessments, hazard analysis) across product lines; ensure risk files are current, properly documented, and integrated into design and manufacturing decisions.
• Lead design transfer activities, defining readiness criteria and ensuring manufacturing processes, documentation, and quality controls are fully established prior to production scale-up.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, or a related field.
• 7+ years of progressive experience in quality, with at least 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 from concept through launch, including DHF management.
• Demonstrated experience managing supplier quality and external manufacturing (CDMO) relationships, including audits, quality agreements, and corrective action programs.
• Deep expertise in quality systems and documentation practices (e.g., DHF, SOPs, change control, CAPA); experience building these systems in an early stage or startup environment strongly preferred.
• Strong command of risk management principles and tools (FMEA, hazard analysis, risk-benefit); able to drive risk decisions at an organizational level.
• Exceptional attention to detail with the ability to balance strategic thinking and hands-on execution in a fast-paced, resource-constrained startup environment.
• Excellent cross-functional leadership and communication skills; able to influence without authority, build quality culture, and represent the quality function at the executive level.

Preferred

• Working knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR/QMSR), and/or GMP, CE IVD, UK, CA, UL frameworks; experience preparing for or navigating regulatory inspections a plus
• Experience scaling quality systems from RUO or early-stage through IVD or regulated product development
• Exposure to instrumentation, software and/or reagent-based products