{"id":1282265,"url":"https://alion.io/job/artis-biosolutions-associate-director-quality-systems","title":"Associate Director, Quality Systems","company":{"id":680472,"name":"Artis BioSolutions","domain":"artisbiosolutions.com","url":"https://alion.io/company/artisbiosolutions","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Watertown, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":141000,"max_usd":268000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":599},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-25T23:17:46Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-16T00:17:22Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"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.\nThe 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.\nScope of Responsibilities\nOwn 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.\n\nEstablish and maintain the quality manual, quality policies and the governing procedure hierarchy.\n\nServe as the process owner for core quality systems including\n\nDocumentation Management\n\nTraining\n\nDeviations, CAPA, Effectiveness Checks\n\nChange Control\n\nSupplier Quality and Change Management\n\nQuality Risk Management\n\nAudit Management, including Supplier, Client and Internal\n\nImplement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions.\n\nEnsure compliance with applicable regulations and guidance documents\n\nLead the company’s supplier, client and internal auditreadiness program\n\nSupport front-room or back-room audits, oversee timely and high-quality audit responses\n\nOwn the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up\n\nOversee supplier qualification and monitoring program, including risk-based supplier audits and performance management\n\nDefine, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities\n\nLead the quality management review process and escalate significant compliance risks to senior leadership\n\nBuild, lead and develop high-performing Quality Systems team, including recruiting, setting performance objectives, coaching and planning career development discussions\n\nManage and own the Change Control Review Board\n\nPartner with internal cross-functional stakeholders to foster a strong Culture of Quality, promoting shared accountability for compliance and right-first-time performance\n\nInfluence internal cross-functional stakeholders to drive timely closure of quality records\n\nRequired Experiences\nEducation\nMinimum Bachelor’s degree is STEM, such as biology, chemistry and engineering\n\nExperience\n8+ years of Quality experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy\n\n5+ years of effective management and strong leadership experience\n\nKnowledge & Skills\nSubject matter expertise in Quality Systems in a GMP biotech setting\n\nPreferred experience with Veeva Vault\n\nRelevant phase-appropriate GMP experience\n\nPreferred Qualifications\nPreferred ASQ certification\n\nPhysical / Work Requirements\nWork environment: Office\n\nOn-site expectations: 3 days on site per week\n\nPhysical requirements: Standing, light lifting, ability to wear PPE when required\n\nTravel: None\n\nSchedule requirements: Monday - Friday, administrative hours\n\nOther requirements: N/A\n\nTo Apply\nPlease submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above.","description_format":"text","description_chars":3965,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Synthetic Biology","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-26T03:19:11Z"}],"visa":[],"liveness":{"score":74,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.819,"p_room":0.9,"age_days":19,"expected_fill_days":30,"reasons":["conf:0","win:mid"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/artis-biosolutions-associate-director-quality-systems","json_url":"https://alion.io/job/artis-biosolutions-associate-director-quality-systems.json","meta":{"generated_at":"2026-10-16T01:37:04Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":2538,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":680472},"rest":"https://alion.io/mcp/rest/get_company?id=680472"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fartis-biosolutions-associate-director-quality-systems"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fartis-biosolutions-associate-director-quality-systems"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fartis-biosolutions-associate-director-quality-systems"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/artis-biosolutions-associate-director-quality-systems\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fartis-biosolutions-associate-director-quality-systems"}]}