{"id":3126614,"url":"https://alion.io/job/seran-bioscience-associate-director-quality-systems-and-compliance","title":"Associate Director, Quality Systems and Compliance","company":{"id":686143,"name":"Serán Bioscience","domain":"seranbio.com","url":"https://alion.io/company/seranbio","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"A","score":95,"open_postings":16,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":188,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Operations","role_family":"Operations","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bend, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":124000,"max_usd":235000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1623},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"ICH Guidelines","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-22T23:18:50Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-31T17:52:25Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. This role serves as the primary owner of inspection readiness, regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring activities.\nThe Associate Director partners closely with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and ensure sustainable compliance as the organization advances commercial manufacturing capabilities. This position serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to cGMP compliance oversight.\nLeader Responsibilities\nLeads and develops a high-performing Quality organization\nProvides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy\nEstablish clear departmental goals aligned with organizational quality and operational objectives\nConducts performance reviews and ensure staff maintain appropriate training and GMP qualifications\nFosters a culture of quality ownership, compliance, and continuous improvement\nOversees daily workflow of the department\nDuties & Responsibilities\nLead the site's inspection readiness program and maintain a state of continuous readiness.\nMonitor evolving regulatory expectations and assess potential impacts to the Quality Management System.\nConduct routine compliance assessments to identify gaps and opportunities for improvement.\nDrive remediation activities associated with inspection observations, compliance risks, and quality system weaknesses.\nSupport implementation of compliance initiatives necessary to maintain commercial manufacturing readiness.\nRegulatory Inspection Management:\nServe as Quality lead for health authority inspections.\nCoordinate inspection preparation activities across all functional areas.\nLead inspection logistics, document management, response coordination, and inspection support activities.\nFacilitate timely and effective responses to regulatory observations.\nTrack regulatory commitments through completion and effectiveness verification.\nClient Audit Program:\nManage customer audit preparation and support activities.\nPartner with clients to facilitate quality due diligence, qualification, and surveillance audits.\nCoordinate audit logistics and observation responses.\nTrack completion of corrective and preventive actions resulting from client audits.\nTrend audit observations to identify recurring compliance risks.\nInternal Audit Program:\nDevelop and maintain the annual internal audit schedule.\nExecute risk-based internal audits across manufacturing, laboratory, warehouse, engineering, supplier quality, and quality systems functions.\nAssess effectiveness of quality system implementation and compliance.\nCommunicate audit findings and recommendations to management.\nVerify implementation and effectiveness of corrective actions.\nSupplier Quality Management:\nManage the Supplier Qualification Program.\nEnsure risk-based qualification and monitoring of suppliers, contract laboratories, consultants, contractors, and critical service providers.\nReview supplier performance metrics and quality trends.\nCoordinate supplier audits and periodic evaluations.\nSupport quality agreements and supplier quality governance activities.\nEscalate supplier-related quality risks to management.\nQuality Metrics & Management Review Program:\nCoordinate and facilitate Site Management Review processes.\nCompile quality system performance data and compliance metrics.\nPresent key compliance trends, risks, and quality indicators to leadership.\nTrack management review actions through closure.\nEnsure management review activities support executive decision-making and resource planning.\nDevelop and maintain compliance dashboards and performance metrics.\nTrend quality system performance and identify emerging compliance risks.\nMonitor key performance and compliance indicators including.\nProvide routine compliance updates to site leadership.\nParticipate in development of annual quality objectives.\nMonitor quality system health and identify compliance trends requiring escalation.\nProvide compliance guidance to cross-functional teams.\nCompliance Governance & Risk Management\nSupport and maintain the site’s Data Integrity Compliance Program\nProvide assessments of computerized systems and data governance controls\nParticipate in investigations involving data integrity concerns\nPromote risk-based decision making throughout the organization.\nFacilitate quality risk assessments related to compliance, product quality, and patient safety.\nEnsure risks are appropriately documented, mitigated, and escalated when necessary.\nSupport implementation of ICH Q9 principles within quality systems and operations.\nRequired Skills & Abilities\nBroad knowledge of FDA and international regulations related to cGMPs and commercial drug product manufacturing.\nExperience organizing and managing work responsibilities while working independently with minimal oversight.\nTime and project management skills with the ability to multi-task and meet deadlines.\nExcellent verbal and written communication skills. \nExcellent interpersonal and customer service skills. \nExcellent organizational skills and attention to detail.\nStrong analytical and problem-solving skills.\nStrong supervisory and leadership skills.\nAbility to prioritize tasks and to delegate them when appropriate. \nProficient with Microsoft Office Suite or related software.\nEducation & Experience\nBachelor's Degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or related discipline required. Advanced degree preferred.\nMinimum 8 years of pharmaceutical, biotechnology, medical device, or CDMO quality experience.\nMinimum 3 years of leadership experience within Quality Compliance, Quality Systems, or related quality functions.\nExperience in supporting commercial manufacturing operations required.\nExperience supporting FDA and / or EU regulatory inspections.\nDemonstrated knowledge of cGMP regulations and quality system requirements.\nExperience with electronic Quality Management Systems (eQMS).\nPhysical Requirements\nProlonged periods of sitting or standing at a desk and working on a computer.\nMust be able to lift up to 15 pounds at times.\nAdheres to consistent and predictable in-person attendance","description_format":"text","description_chars":6827,"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":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-23T02:14:14Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":8,"expected_fill_days":188,"reasons":["conf:3","win:early"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/seran-bioscience-associate-director-quality-systems-and-compliance","json_url":"https://alion.io/job/seran-bioscience-associate-director-quality-systems-and-compliance.json","meta":{"generated_at":"2026-10-31T18:01:46Z","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":28232,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":686143},"rest":"https://alion.io/mcp/rest/get_company?id=686143"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fseran-bioscience-associate-director-quality-systems-and-compliance"},{"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%2Fseran-bioscience-associate-director-quality-systems-and-compliance"},{"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%2Fseran-bioscience-associate-director-quality-systems-and-compliance"},{"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/seran-bioscience-associate-director-quality-systems-and-compliance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fseran-bioscience-associate-director-quality-systems-and-compliance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3126614}},{"tool":"search_jobs","arguments":{"company":"seranbio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3126614},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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