{"id":3536959,"url":"https://alion.io/job/uniqure-associate-director-quality-control","title":"Associate Director, Quality Control","company":{"id":2079697,"name":"uniQure","domain":"uniqure.com","url":"https://alion.io/company/uniqure-com","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":188000,"max":228000,"currency":"USD","period":"year","gross":null,"usd_annual":228000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"FMEA","optional":false},{"name":"GDPR","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-10-30T15:02:58Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-03T15:54:19Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Place in the Organization\nAt uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.\nThe Associate Director, Quality Control is responsible for managing all operational activities for in-process, release, and stability testing for clinical and commercial products. The candidate will be responsible for relationship management, Contract Testing Organization (CTO) selection, and CTO strategies. This position works closely with Operations, Quality Assurance, and Regulatory Affairs to develop and maintain a comprehensive program that ensures consistent quality throughout the production platform and lifecycle.\nKey result areas (major duties, accountabilities, and responsibilities) :\nResponsible for external quality testing at CTO’s (including in-process, release, and stability); ensures complete documentation for compliance with cGMPs\nMaintains relationships with CTO’s to ensure Quality Agreements, Statement of Work (SOW), and Manufacturing Service Agreements (MSA) are initiated and updated accordingly\nOversee testing programs including: Assay Controls, Starting Materials, Reference Standards, Product Release, Stability \nOversees budgeting for CTO’s; including contracts and purchase orders\nSupport and facilitate deviations and investigations\nSupport long-term planning of QC lab capabilities and capacity\nResponsible for coordinating with AD and QCTS for the implementation of new technologies into CTO network\nChange notification management\nData analysis for release data\nCoordination and drafting of Annual Product Review sections\nCoordination of Annual Method Reviews\nCoordination/review of compendial methods for compliance\nActive participant in the management and direction of the overall QC programs and requirements\nQualifications\nBachelor’s degree in Scientific discipline\n10 - 12 years of relevant GMP experience in pharma/biotech company\nExperience working in a GMP testing environment\nExperience managing CTO’s\nWell versed in cGMP/ICH/FDA/EU regulations and guidelines\nProficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)\nProficient in an electronic document management system/electronic QMS\nExperience using Risk Management Tools such as FMEA, 5Ms, 5 Whys, etc.\nProject management skills preferred\nCore competencies\nStrong communication skills\nStrong organizational skills\nDecision making and problem solving skills\nAttention to detail\nCapable of working with minimal supervision\nAbility to work well with diverse groups\nAbility to manage multiple activities with challenging timelines\nThe estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.\nUS Salary Range\n$188,000—$228,000 USD\nuniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact .\n uniQure posts all open positions exclusively on our official Careers page and LinkedIn. We do not recruit through any other job boards, third-party websites, or unsolicited outreach via text or messaging apps. All legitimate communication from uniQure’s Talent Acquisition team will come from an @uniqure.com email address. We will never request financial information nor payment of any kind during the application process. If you receive suspicious outreach claiming to be from uniQure, do not respond or share personal information. Inquiries can be made via .\nuniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information - including disclosures for California residents under the CCPA and for applicants under the GDPR - please review our applicant privacy notice.","description_format":"text","description_chars":5176,"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":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Cell & Gene Therapy","Genomics & Genetic Testing"],"lifecycle":[{"event":"open","at":"2026-10-30T17:58:18Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":152500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":3,"expected_fill_days":50,"reasons":["conf:3","win:early"],"computed_at":"2026-11-03T05:54:40Z"},"pay":{"stated_usd_annual":228000,"is_top_pay":true},"html_url":"https://alion.io/job/uniqure-associate-director-quality-control","json_url":"https://alion.io/job/uniqure-associate-director-quality-control.json","meta":{"generated_at":"2026-11-03T19:20:59Z","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":1483,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":2079697},"rest":"https://alion.io/mcp/rest/get_company?id=2079697"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Funiqure-associate-director-quality-control"},{"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%2Funiqure-associate-director-quality-control"},{"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%2Funiqure-associate-director-quality-control"},{"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/uniqure-associate-director-quality-control\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Funiqure-associate-director-quality-control"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3536959}},{"tool":"search_jobs","arguments":{"company":"uniqure.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3536959},"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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