Countable Labs
Senior Manager/Associate Director, Quality
Palo Alto, CA · Director · Full-time
Sponsorship not specifiedDetected 2 days ago
Product ManagementGMPFDA RegulatoryBioinformaticsPCRMedical DevicesLeadershipCommunicationCollaboration
About the role
- 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.
- 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.
Responsibilities
- 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.
- 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.
- 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.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, or a related field.
Nice to have
- We're a fast-growing startup fueled by innovation, collaboration, and a mission-driven spirit.
- This is a full-time position.
- Define, track, and report on quality KPIs (e.g., internal and external defects, CAPA cycle time) to senior leadership
- Establish and oversee training programs and compliance requirements across all departments, ensuring readiness for internal and external audits.
- 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.
Apply directly at Countable Labs →Create a free account for alerts like thisView Countable Labs immigration profile
This listing is sourced directly from Countable Labs's careers page and normalized into a canonical job model.