Head of Quality

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).

Key Responsibilities

Quality Strategy & Organizational Leadership

• 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.

Site Quality

• 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 automation, software engineering, and IT teams to ensure that systems supporting GLP and GCP studies are qualified, validated, and maintained to regulatory standards (GAMP 5, ALCOA+).
• Evaluate and ensure new laboratory technologies and platforms are qualified prior to use in regulated studies.

Study Quality — QAU (GLP & GCP)

• Oversee Quality Assurance Unit functions for all GLP-regulated nonclinical studies in accordance with 21 CFR Part 58 and OECD Principles of GLP, including phase inspections, facility inspections, and final report reviews.
• Extend QAU oversight to GCP-regulated bioanalytical studies supporting clinical programs, ensuring alignment with ICH E6(R3), applicable FDA/EMA guidance, and study-specific requirements.
• Review and approve GLP study plans (protocols), amendments, and final reports; issue QA statements and inspection findings.
• Oversee the archivist function and study archive integrity. Maintain the master schedule; oversee GLP archive integrity and access controls.
• Provide quality oversight of bioanalytical method validation and sample analysis conducted under GLP/GCP, ensuring compliance with applicable regulatory guidance (e.g., FDA BMV guidance, EMA guidelines).
• Liaise directly with sponsors, study directors, and principal investigators on study-specific compliance matters.

Qualifications

• Education: Bachelor's degree in a scientific discipline required; advanced degree (MS, PhD) strongly preferred.
• Experience: Minimum 12–18 years of progressive experience in Quality Assurance, with at least 6+ years in a senior leadership role building or running a quality organization. Experience in both GLP and GCP environments is required.
• Executive Leadership: Demonstrated experience operating as a senior quality executive — setting strategy, owning budget and headcount, and reporting to CEO, Board, or equivalent leadership bodies.
• Regulatory Expertise: Deep working knowledge of 21 CFR Part 58 (FDA GLP), OECD Principles of GLP and OECD Consensus Documents, ICH E6 (GCP), and global regulatory expectations for bioanalytical laboratories. Familiarity with EMA, PMDA, and other major international authorities is a plus.
• QAU Experience: Demonstrated experience performing formal QAU functions (study/phase inspections, facility inspections, final report review, QA statements) under GLP; GCP QA oversight of bioanalytical studies is strongly preferred.
• Lab Systems / CSV: Working knowledge of computerized system validation (GAMP 5), 21 CFR Part 11 / Annex 11, and data integrity (ALCOA+) in a regulated laboratory context.
• People Leadership: Proven track record of building and managing multi-tiered quality teams and leaders. Ability to develop talent, manage performance, and cultivate an accountable, growth-oriented team culture.
• Inspection Experience: Experienced in hosting and managing FDA, client, and third-party regulatory inspections. Ability to lead real-time inspection management and deliver high-quality written responses.
• Communication & Influence: Exceptional written and verbal communication skills. Proven ability to influence the executive team, Board, scientists, engineers, and external clients or regulators.
• Analytical & Strategic Judgment: Strong capacity to synthesize complex regulatory, technical, and operational data into clear, strategic quality decisions that shape company direction.