{"id":2240880,"url":"https://alion.io/job/lonza-global-operational-quality-specialist","title":"Global Operational Quality Specialist","company":{"id":679681,"name":"Lonza","domain":"lonza.com","url":"https://alion.io/company/lonza","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":77,"open_postings":73,"ghost_share":0,"stale_share":0.932,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Greenwood, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":96000,"max_usd":187000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1394},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"LIMS","optional":false},{"name":"Mandiant capa","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-09-30T00:00:00Z","employer_posted_date":"2026-09-30","last_verified_at":"2026-10-27T12:41:44Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"The Global Operational Quality Specialist coordinates and drives the consistent execution of Operational Quality Assurance/Quality Control (QA/QC) processes across the global network. The role ensures effective implementation of quality governance, standards, performance monitoring, training, and quality systems through cross-functional collaboration with global and site quality teams.\nThe function supports harmonization of QA/QC practices, coordinates global quality initiatives, monitors execution, and drives timely follow-up of quality actions, risks, and improvement opportunities. The position also facilitates knowledge sharing, strengthens inspection readiness, and promotes sustainable operational quality performance across sites.\nWhat you will do\nDefine and maintain the global Quality governance model, including governance structures, KPI/KQI frameworks, reporting processes, and inspection-ready performance management.\n\nCoordinate global escalation processes, oversee CAPA governance and effectiveness, and drive follow-up of cross-site quality risks, critical quality events, and operational QA/QC issues.\n\nDefine, monitor, and coordinate execution of the Global Quality Plan, Annual Product Reviews, Management Reviews, and strategic quality initiatives aligned with business priorities.\n\nDevelop and drive global Quality Culture and Quality Excellence programs, including communication, best practice sharing, and execution governance across all sites.\n\nDevelop, implement, and continuously improve global QA/QC standards, corporate SOPs, product release frameworks, control strategies, and quality oversight models.\n\nDrive global harmonization of quality practices through structured gap assessments, implementation follow-up, and inspection-ready quality standards across sites.\n\nDefine, implement, and maintain the global GxP training framework, including governance, curricula, training effectiveness, and Learning Management System processes.\n\nSupport the global coordination of critical quality events by establishing investigation principles, promoting robust root cause analysis, and defining technical expectations for CAPA effectiveness.\n\nLead quality change management for global operational quality processes by initiating global changes, performing quality impact assessments, and ensuring cross-site implementation.\n\nSupport business growth by providing QA/QC expertise for strategic initiatives, driving process optimization and digitalization, and embedding continuous improvement into operational quality practices.\n\nWhat we are looking for\nMSc in Pharmacy, Biotechnology, (Bio-)Engineering, Life Sciences, or a related scientific or technical discipline.\n\nMinimum of 10 years of experience in a GMP-regulated environment, including global quality systems, operational QA/QC, quality governance, and cross-site quality initiatives.\n\nStrong technical expertise in GMP, QMS, LIMS, product testing and release, validation, data integrity, inspection readiness, CAPA, change management, and regulatory expectations.\n\nProven ability to develop, harmonize, and implement global quality standards, governance frameworks, and operational quality processes, driving continuous improvement and operational excellence.\n\nStrong analytical and digital capabilities, including KPI/KQI development, trend analysis, SharePoint, and digital reporting dashboards and automation tools to support data-driven decision-making.\n\nExcellent coordination, stakeholder management, and communication skills, with the ability to influence across global QA, QC, Operations, Validation, and senior leadership while delivering practical, scalable, and sustainable quality solutions\n\nWillingness to travel (up to 10%)","description_format":"text","description_chars":3724,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-11T01:03:38Z"}],"visa":[],"liveness":{"score":45,"band":"ok","label":"Likely open","p_open":1,"p_active":0.606,"p_room":0.75,"age_days":27,"expected_fill_days":34,"reasons":["conf:5","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/lonza-global-operational-quality-specialist","json_url":"https://alion.io/job/lonza-global-operational-quality-specialist.json","meta":{"generated_at":"2026-10-27T17:58:54Z","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 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