--- title: 'Associate Director, Quality Systems at Artis BioSolutions' canonical: 'https://feeny.ai/job/associate-director-quality-systems-artis-biosolutions-watertown-bvw59taspn0w' type: 'job' last_seen: '2026-10-15' --- # Associate Director, Quality Systems at Artis BioSolutions - **Company:** Artis BioSolutions - **Location:** Watertown, MA - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-09-25 - **Last confirmed live:** 2026-10-15 - **Apply:** https://jobs.lever.co/landmarkbio/bff2ba13-0629-4f61-b714-7b4a3426652f ## Job description The Associate Director, Quality Systems leads the strategy, design and continuous improvement of the Quality Management System supporting Artis BioSolutions' cell therapy, viral vector and fill-finish operations. The role owns core quality systems, including document management, change control, deviations, CAPA, training, supplier quality, and risk management. This individual will also lead audit readiness, and supplier and client audits. Throughout, it ensures these systems remain phase-appropriate, scalable and compliant with regulatory expectations. The Associate Director builds and leads the Quality Systems team and partners closely with Technical Operations, Quality Control, Process Development and Data Technology Integrations. Through metrics, risk-based decision-making and a strong quality culture, the position enables the Quality department to support operations efficiently. In doing so, it advances Artis BioSolutions' mission of helping innovators bring life-changing therapies from bench to clinic. Scope of Responsibilities - Own the strategy, design and continuous improvement of the Quality Management System, ensuring it is phase-appropriate, scalable and aligned with company growth from early clinical through late-stage development. - Establish and maintain the quality manual, quality policies and the governing procedure hierarchy. - Serve as the process owner for core quality systems including - Documentation Management - Training - Deviations, CAPA, Effectiveness Checks - Change Control - Supplier Quality and Change Management - Quality Risk Management - Audit Management, including Supplier, Client and Internal - Implement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions. - Ensure compliance with applicable regulations and guidance documents - Lead the company’s supplier, client and internal audit readiness program - Support front-room or back-room audits, oversee timely and high-quality audit responses - Own the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up - Oversee supplier qualification and monitoring program, including risk-based supplier audits and performance management - Define, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities - Lead the quality management review process and escalate significant compliance risks to senior leadership - Build, lead and develop high-performing Quality Systems team, including recruiting, setting performance objectives, coaching and planning career development discussions - Manage and own the Change Control Review Board - Partner with internal cross-functional stakeholders to foster a strong Culture of Quality, promoting shared accountability for compliance and right-first-time performance - Influence internal cross-functional stakeholders to drive timely closure of quality records Required Experiences Education - Minimum Bachelor’s degree is STEM, such as biology, chemistry and engineering ## Experience - 8+ years of Quality experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy - 5+ years of effective management and strong leadership experience Knowledge & Skills - Subject matter expertise in Quality Systems in a GMP biotech setting - ## Preferred experience with Veeva Vault - Relevant phase-appropriate GMP experience ## Preferred Qualifications - ## Preferred ASQ certification Physical / Work Requirements - Work environment: Office - On-site expectations: 3 days on site per week - Physical requirements: Standing, light lifting, ability to wear PPE when required - Travel: None - Schedule requirements: Monday – Friday, administrative hours - Other requirements: N/A To Apply Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above. Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. ## About Artis BioSolutions ## Company Overview - **One-liner**: Artis BioSolutions is an integrated platform for synthetic DNA production and advanced therapy manufacturing, accelerating genetic medicines from discovery through commercial GMP production. - **Entity Type**: Private (backed by Oak HC/FT; acquired Landmark Bio in 2025) - **Headquarters**: Carlsbad, California, United States (also operations in Watertown, MA and Bilbao, Spain) - **Founded**: 2024 - **Founders**: Brian Neel (CEO) and Michael Houston (Co-Founder & CSO) ## Core Business - **Primary industry**: Contract Development and Manufacturing Organization (CDMO) for genetic medicines; biotechnology - **Target customers**: Biopharma companies developing mRNA therapies, gene editing, viral vectors, cell therapies (CAR-T, CAR-NK, iPSCs), vaccines, and emerging modalities - **Mission**: To advance genetic medicines and biologics from early development to market by replacing fragmented supply chains with an integrated, synthetic DNA-powered platform. ## Products & Services - **Synthetic DNA (oDNA)**: Proprietary enzymatic manufacturing of truly synthetic, plasmid-free DNA at RUO and GMP grades, delivered in 2 weeks (RUO) or 3-4 weeks (GMP) up to gram scale. - **Cell Therapies**: Autologous and allogeneic cell therapy development and manufacturing, including CAR-T, CAR-NK, iPSCs, MSCs, and organoids. - **Viral Vectors**: AAV and lentiviral vector production from research scale through GMP. - **mRNA and LNP**: In vitro transcription, formulation, and translational development. - **Emerging Modalities**: Support for extracellular vesicles, non-viral delivery platforms, and novel technologies. - **Integrated Services**: CMC strategy, regulatory support, process and formulation development, analytical development, GMP manufacturing, and fill/finish. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private) - **Key Metric**: Total funding undisclosed; backed by Oak HC/FT; acquired Landmark Bio in 2025 for an undisclosed sum. - **Notable Investors/Partners**: Oak HC/FT (lead venture and growth equity firm) - **Growth Signals**: - Emerged from stealth in April 2025 with acquisition of Landmark Bio (~75 employees). - Combined headcount ~80 employees (as of early 2025), with LinkedIn showing +80% YoY growth. - Dual manufacturing sites in the US (Watertown, MA) and EU (Bilbao, Spain). - 2-week RUO synthetic DNA production timeline – significantly faster than industry standard. ## Competitive Advantages - **Integrated platform** that replaces fragmented supply chains – one vendor from synthetic DNA through GMP fill/finish. - **Proprietary enzymatic oDNA** eliminates plasmid dependency, reducing contamination risk and accelerating timelines. - **Multi-modality capability** (mRNA, viral vectors, cell therapies, emerging) from a single infrastructure. - **US and EU GMP manufacturing** enables global supply chain resilience. - **Flexible engagement models** from defined-scope projects to deep co-development partnerships. ## Strategic Focus - Build a portfolio of subsidiaries (starting with Landmark Bio) to create a single-source CDMO for complex genetic medicines. - Reduce project timelines and manufacturing costs for customers while maintaining quality. - Pursue additional strategic acquisitions in partnership with Oak HC/FT to expand capabilities and respond to market shifts (e.g., mRNA, gene editing). - Scale enzymatic synthetic DNA production as a foundational technology for all genetic medicine modalities. ## Why Work Here - **Mission-driven environment**: Directly contribute to bringing life-changing genetic therapies to patients faster. - **Rapid growth**: Company emerged from stealth in 2025 and is actively scaling – potential for career advancement. - **Geographic options**: Opportunities at the Carlsbad, CA headquarters, Watertown, MA (Landmark Bio site), and Bilbao, Spain. - **Cutting-edge technology** – work with synthetic DNA, mRNA, viral vectors, cell therapy – not just a traditional CDMO. - **Backed by top-tier investors** (Oak HC/FT) providing stability and long-term vision. - **Culture highlights**: Small, agile team with strong scientific leadership; collaborative approach with clients; emphasis on quality and innovation. - **Perks**: Not explicitly listed, but as a biotech CDMO, likely includes standard benefits, potential equity, and opportunities to work on groundbreaking therapies. ## Sources 1. [Artis BioSolutions Official Website](https://artisbiosolutions.com) 2. [Artis BioSolutions LinkedIn](https://linkedin.com/company/artis-biosolutions) 3. [Artis BioSolutions Leadership Page (Landmark Bio)](https://landmarkbio.com/staff-category/artis-biosolutions-leadership-team/) 4. [San Diego Business Journal – Artis BioSolutions Emerges from Stealth](https://sdbj.com/life-sciences/artis-biosolutions-emerges-from-stealth-with-acquisition/) ## Other roles at Artis BioSolutions - [Downstream Associate Scientist (Contract 3 to 6 months)](https://feeny.ai/job/downstream-associate-scientist-contract-3-to-6-months-artis-biosolutions-kcygep0skae3) — Watertown, MA - [Manager, Environmental Health & Safety (EHS)](https://feeny.ai/job/manager-environmental-health-safety-ehs-artis-biosolutions-watertown-chqjw596f5p4) — Watertown, MA - [Research Associate - Analytics, Cell & Gene Therapies](https://feeny.ai/job/research-associate-analytics-cell-gene-therapies-artis-biosolutions-watertown-q7enzvx81qm8) — Watertown, MA