QA Specialist

About Us 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 scientists and engineers who are tired of the status quo and are ready to apply their skills to solve hard problems at scale. We 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. Quality Assurance Specialist Dash Bio is seeking a detail‑oriented and motivated Quality Assurance Specialist to support day‑to‑day quality operations across our site, laboratory systems, and GLP‑regulated study programs. This individual will execute core Quality Assurance Unit (QAU) tasks for bioanalytical studies under GLP (21 CFR Part 58, OECD Principles of GLP), assisting with inspections, documentation review, and quality system upkeep under the guidance of Quality leadership. This is a hands‑on, execution‑focused role, ideal for someone early in their quality career who wants to build deep, practical GLP/GCP experience in a fast‑paced, technology‑first bioanalytical lab environment. The Specialist will work closely with the Director, Site Quality and senior QA staff to carry out routine site quality, lab systems, and study quality activities. Key Responsibilities Support day‑to‑day compliance activities at the Waltham facility, ensuring adherence to FDA, OECD, and applicable GLP regulatory requirements. Assist with Quality Management System (QMS) activities: document control, logging and tracking CAPAs, deviations, change controls, log books, training records, JDs/CVs, lab investigations, etc. Help prepare materials and documentation for regulatory inspections and client audits under the direction of Quality leadership. Compile site quality metrics and data for KPI tracking and Quality Management Review presentations. Conduct routine self‑inspections and walkthroughs of site and laboratory areas, and document findings for QA leadership review. Conduct routine review of Enterprise systems such as QMS, Environmental Monitoring, and CMMS to check for quality trends, environmental trends, and missed calibration/maintenance records. Review impact assessments of SaaS system changes and assist in documenting change control reviews. Support coordination with lab and IT teams to track qualification and validation status of systems supporting GLP studies. Assist with Quality Assurance Unit functions for GLP‑regulated non‑clinical studies, including scheduling and supporting phase inspections and facility inspections. Perform first‑pass reviews of GLP study plans (protocols), amendments, and final reports, flagging issues for senior QA review. Support the archivist in maintaining the study archive, master schedule, and archive access controls. Assist with quality checks of bioanalytical method validation and sample analysis documentation conducted under GLP. Help track and follow up on open QA findings, action items, and CAPAs related to specific studies. Preferred Skills glp qms Benefits Health Insurance Vision Insurance 401(k) Matching Paid Time Off (PTO) Paid Holidays Qualifications Education: Bachelor’s degree in a scientific discipline required (e.g., biology, chemistry, biochemistry, or related field). Experience: 1–6 years of experience in Quality Assurance, quality control, or a related regulated laboratory role. Prior exposure to GLP environments preferred; GCP exposure a plus. Regulatory Knowledge: Working familiarity with 21 CFR Part 58 (FDA GLP) and OECD Principles of GLP. Exposure to ICH E6 (GCP) is a plus but not required. QAU Exposure: Some experience supporting or observing QAU functions under GLP is preferred. Attention to Detail: Strong organizational skills and attention to detail, with the ability to manage multiple documentation and tracking tasks simultaneously. Communication: Solid written and verbal communication skills; comfortable documenting findings clearly and coordinating with lab and study staff. Systems Familiarity: Basic familiarity with document control systems, CAPA/deviation tracking tools, and general data integrity principles (ALCOA+) is a plus. Collaboration: Eagerness to learn from senior QA staff and grow into greater ownership of quality processes over time. 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 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 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 QMS for all aspects of 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 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. Oversee quality assurance unit functions for all GLP‑regulated non‑clinical studies, 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. Senior / Principal Product Designer We are seeking a Senior / Principal Product Designer to spearhead the user experience and interface design across our growing digital ecosystem. You will own the design of the portals, dashboards, and tools our external biopharma clients use to interact with our platform while also playing a critical role in evolving and optimizing the complex internal interfaces that power our lab automation platforms. In this role, you will design intuitive, polished, and trustworthy experiences for complex scientific data. You will mock up high‑fidelity prototypes to iterate on designs, test concepts, and gather rapid feedback from users and stakeholders. You will bridge the gap between product strategy, design, and engineering to deliver software our users love. Key Responsibilities Lead the UI/UX design process for external, client‑facing web applications, from user research and wireframing to high‑fidelity prototyping and testing. Create interactive mock‑ups and prototypes to effectively communicate design concepts, gather stakeholder feedback, and rapidly iterate on solutions before engineering hand‑off. Design and build complex, interactive data visualizations that allow clients to easily interpret their bioanalytical results. Take ownership and evolve our comprehensive design system and component library to ensure visual consistency and accelerate development. Act as a strategic partner to the engineering team, providing hands‑on design guidance and innovative solutions to tackle complex, non‑standard user interface challenges. Conduct regular design QA and comprehensive UI reviews of developer implementations to ensure the final product maintains a high degree of visual polish and usability. Serve as the primary point of contact and strategic partner for our external brand agency, ensuring seamless alignment between external brand identity and internal product experiences. Partner with the Marketing team to provide high‑level design support for ad‑hoc campaigns, collateral, and digital assets. Qualifications 5–7+ years of experience in product design, UI/UX, and frontend development. (Principal level requires 7+ years with a track record of architectural design influence and leading major product launches). Mastery of modern design tools (Figma, Illustrator, Photoshop, etc.) and a strong portfolio demonstrating experience with B2B SaaS, customer portals, or data‑rich enterprise applications. Actively uses AI tools (Cursor, Copilot, Claude, etc.) to accelerate design and development workflows. Comfortable prompting, iterating, and shipping faster without sacrificing quality. Solid understanding of modern web capabilities (HTML, CSS, React) to ensure smooth engineering hand‑offs and the technical feasibility of your designs. Proven experience designing interfaces that handle complex data sets, analytics, and reporting for external users. Excellent ability to articulate design decisions, present to stakeholders, and collaborate with a cross‑functional team of engineers and product managers. Location Waltham, Massachusetts, United States #J-18808-Ljbffr