Director, Site Quality (GLP)

Job Title: Director, Site Quality (GLP)

Division/Function: Quality

Reports to: Head of Compliance

Location: 21 Hickory Dr, Waltham, MA 02451 (On-Site)

Direct Reports: Yes

FLSA Status: Exempt

Last Updated: May 2026

Our Mission

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.

Company Summary

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 industry change agents who are tired of the status quo and are ready to apply their skills to solve hard problems at scale. We are a place where employees are stretched to do the best work of their career.

Dash Bio is seeking an experienced, strategic, and technically forward-thinking Director of Site Quality to serve as the senior quality leader across our site operations, laboratory systems, and regulated study programs. This individual will function as the Quality Assurance Unit (QAU) lead for bioanalytical studies under both GLP (21 CFR Part 58, OECD Principles of GLP) and GCP frameworks, providing independent oversight across all regulated activities — from facility and systems compliance to study conduct and data integrity.

This leader will develop the Site Quality team and will partner with scientific, automation, and technology teams to architect a laboratory and site environment that is scalable, inspection-ready, and built for a next-generation bioanalysis environment.

This is a site-based role across three quality domains: site quality , lab systems quality , and study quality (GLP/GCP QAU functions) .

Key Responsibilities

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.
• Help in the 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)

• Perform and lead 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.
• Partner with QA leadership to 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.
• Help the archivist maintain the study archive. 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 8–12 years of progressive experience in Quality Assurance, with at least 4 years in a leadership or management role. Experience in both GLP and GCP environments is required.
• 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 managing quality teams. 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 cross-functional stakeholders, including executive leadership, scientists, engineers, and external clients or regulators.
• Analytical Judgment: Strong capacity to synthesize complex regulatory, technical, and operational data into clear, strategic quality decisions.

What We Offer

• Opportunity to shape the quality function at a technology-first bioanalysis company defining the future of drug development.
• Collaborative, intellectually ambitious company culture.
• Competitive salary and comprehensive benefits package.
• Meaningful career ownership and visibility into executive leadership.
• Professional development and advancement opportunities in a high-growth environment.

How to Apply

Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and interest in joining Dash Bio to ***email_hidden***.

Dash Bio is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees