Head of Quality

Dash accelerates drug development. By fusing advanced automation-native lab workflows and integrated software into a unified platform, we provide the biopharma industry with the high-velocity, high-quality, data-driven development solutions required to get life-saving therapies to patients faster. Dash seeks to continuously improve industry KPIs and materially reduce the time and cost to bring a drug to market.

We are building the infrastructure for modern drug development. We are moving beyond the manual, fragmented processes of traditional service providers by taking a technology-first approach to bioanalysis. Our platform is tech-enabled, automated, and GLP-compliant with the goal to industrialize the scientific workflows that act as bottlenecks in the industry. We deliver next-generation preclinical and clinical bioanalysis results with unprecedented speed and precision.

We are a team of builders operating at the intersection of biology, hardware, and code. This is an environment for scientists and engineers who are tired of the status quo and are ready to apply their skills to solve hard problems  don't just run assays, we architect the systems that will define the future of drug development.

We are a place where employees are stretched to do the best work of their career. We are looking for engineers, scientists, and biotechnicians who want to make an impact on the world and leverage their skills in an innovative way.

Dash Bio is seeking an experienced, strategic, and technically forward-thinking Head of Quality to serve as the senior-most quality leader for the company, setting the vision, strategy, and operating model for quality across all site operations, laboratory systems, and regulated study programs. This individual will own the Quality function end-to-end as a member of the senior leadership team, function as the ultimate escalation point for the Quality Assurance Unit (QAU) for bioanalytical studies under both GLP (21 CFR Part 58, OECD Principles of GLP) and GCP frameworks, and provide independent oversight across all regulated activities — from facility and systems compliance to study conduct and data integrity.

This leader will build and scale the Site Quality organization, define Dash's multi-year quality strategy and roadmap, represent Quality to the executive team and Board, and partner with scientific, automation, and technology leadership to architect a quality infrastructure that is scalable, inspection-ready, and built for a next-generation bioanalysis environment as the company expands to new sites and modalities.

This is an enterprise-wide leadership role spanning four domains:
quality strategy & organizational leadership ,
site quality ,
lab systems quality , and study quality (GLP/GCP QAU functions) .

• Set the strategic vision and multi-year roadmap for the Quality organization, aligning quality priorities with Dash's business strategy, growth plans, and platform expansion across sites and service lines.
• Serve as a member of the senior leadership team, representing Quality in executive decision-making and reporting quality performance, risk posture, and strategic initiatives directly to the CEO and Board as needed.
• Build, structure, and scale the Quality organization — including hiring, org design, and succession planning — to support the company's growth from a single-site to a multi-site operation.
• Own the Quality function's budget, headcount planning, and resource allocation, balancing near-term compliance needs against long-term strategic investments.
• Define company-wide quality policy and establish the overarching Quality Management System (QMS) framework that site, lab, and study quality teams operate within.
• Evaluate the quality implications of new business lines, modalities, geographies, or M&A activity, and shape Dash's regulatory and quality strategy accordingly.
• Champion a company-wide culture of quality, data integrity, and continuous improvement, extending quality mindset and accountability beyond the Quality function itself.

• Serve as the senior quality authority for all site-level operations at the Waltham facility and future sites, ensuring compliance with FDA, OECD, EMA, and applicable international GLP/GCP regulatory requirements.
• Ensure compliance with the Quality Management System (QMS) for all things related to the site and the laboratory:
  Document control, CAPA, deviation management, change control, risk management, and training programs.
• Own preparation for and response to regulatory inspections, client audits, and notified body assessments. Own CAPA implementations related to the site and laboratory.
• Establish and monitor site quality metrics and KPIs; present trend analyses and insights at Quality Management Reviews.
• Drive proactive risk management using data-driven approaches and quality intelligence.
• Frequently audit and inspect the site and laboratory areas.
• Partner with…