{"id":786229,"url":"https://alion.io/job/lexeotx-associate-director-quality-systems-and-compliance","title":"Associate Director, Quality Systems and Compliance","company":{"id":679873,"name":"Lexeo Therapeutics","domain":"lexeotx.com","url":"https://alion.io/company/lexeotx","size_band":"201-500","is_staffing_agency":false,"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":["New York, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":158400,"max":207000,"currency":"USD","period":"year","gross":null,"usd_annual":207000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-07-06T20:51:46Z","employer_posted_date":"2026-07-06","last_verified_at":"2026-09-25T02:44:28Z","board_verified":true,"closed_at":null,"days_open":80,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":80},"description":"Role Summary\nWe are seeking an experienced Associate Director, Quality Systems & Compliance to lead strategic oversight and continuous improvement of our Quality Management System (QMS), Document Control for Policies, SOPs, Work Instruction & forms, and GxP as well as some non GxP Training programs. This individual will play a critical role in ensuring our quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining compliance with applicable global regulatory requirements.\nThe successful candidate will be a hands-on leader with extensive experience implementing and managing electronic quality systems, developing and maintaining controlled documentation, and administering enterprise-wide training programs within a biotechnology or pharmaceutical environment.\nPrimary Responsibilities\nProvide strategic leadership and operational oversight for the Quality Management System (QMS), Document Control, and Training functions\nServe as the business owner and subject matter expert for the electronic Quality Management System (eQMS), ensuring system performance, compliance, and continuous improvement\nLead the development, review, approval, implementation, and lifecycle management of Standard Operating Procedures (SOPs), work instructions, policies, and quality records\nOversee document control processes, including document issuance, revision control, archival, and periodic review\nManage GxP and non-GxP training programs, ensuring timely assignment, completion, effectiveness, and compliance with regulatory expectations\nDevelop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement\nPartner with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other cross-functional teams to ensure quality system effectiveness\nSupport internal audits, external audits, regulatory inspections, and supplier audits related to Quality Systems, documentation, and training\nEnsure Quality Systems remain aligned with FDA, EMA, ICH, and applicable global regulatory requirements\nLead and mentor Quality Systems personnel, fostering a culture of compliance, accountability, and continuous improvement.\nRequired Skills and Qualifications\nBachelor's degree in Life Sciences, Engineering, Quality, or a related scientific discipline; advanced degree preferred\n10+ years of Quality Assurance experience withinbiotechnology, pharmaceutical, cell therapy, or gene therapy industries, including progressive leadership responsibilities\nDemonstrated experience managing enterprise Quality Systems in a regulated GxP environment\nAdvanced proficiency with eQMS, preferably ZenQMS, including administration, configuration, workflow management, reporting, and user support\nExtensive experience developing, revising, implementing, and managing Standard Operating Procedures (SOPs) and controlled quality documentation\nDemonstrated expertise managing both GxP and non-GxP training programs, including curriculum development, training assignments, compliance monitoring, and effectiveness assessments.\nPreferred Qualifications\nExperience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic products\nStrong understanding of FDA, EMA, ICH, and global GxP regulations\nExperience leading Quality System implementations, upgrades, or continuous improvement initiatives\nExcellent communication, organizational, and project management skills\nProven ability to influence cross-functional stakeholders and lead through change in a fast-paced, growing organization","description_format":"text","description_chars":3625,"description_truncated":false,"requirements":{"experience_years_min":10,"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":["Health Care","Pharmaceuticals","Cell & Gene Therapy"],"lifecycle":[{"event":"open","at":"2026-09-12T01:59:28Z"}],"liveness":{"score":29,"band":"fade","label":"Fading","p_open":1,"p_active":0.812,"p_room":0.36,"age_days":79,"expected_fill_days":43,"reasons":["conf:2","win:tail","crowd:"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":207000,"is_top_pay":false},"html_url":"https://alion.io/job/lexeotx-associate-director-quality-systems-and-compliance","json_url":"https://alion.io/job/lexeotx-associate-director-quality-systems-and-compliance.json","meta":{"generated_at":"2026-09-25T03:32:19Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3901,"day_limit":5000,"remaining_today":1099,"minute_limit":60,"resets_at":"2026-09-26T00:00:00Z"}}}