{"id":2832589,"url":"https://alion.io/job/lonza-director-sterility-assurance","title":"Director, Sterility Assurance","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":80,"open_postings":75,"ghost_share":0,"stale_share":0.8,"repost_share":0,"time_to_fill_p50_days":34,"computed_at":"2026-10-25T05:49:26Z"}},"role":"MedTech","role_family":"MedTech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":171000,"max_usd":304000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":79},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-24T00:00:00Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-24T02:30:23Z","board_verified":false,"closed_at":null,"days_open":32,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":32},"description":"Today, Lonza is a global leader in life sciences, operating across five continents, Lonza works every day to enable a healthier world. Our greatest scientific solution is talented people working together, devising ideas that help businesses improve lives. In exchange, we empower our employees to own their careers and genuinely make a meaningful difference.\nWe are seeking an experienced Director, Sterility Assurance to provide global leadership for sterility assurance and contamination control across Lonza's sterile manufacturing network. This highly visible role will drive enterprise-wide strategy, governance, and continuous improvement initiatives to ensure world-class biological contamination control and compliance across sterile drug substance and drug product operations.\nKey Responsibilities\nGlobal Sterility Assurance Leadership\nDevelop, implement, and continuously improve biological contamination control strategies addressing viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious agent risks.\n\nDrive and oversee the global sterility assurance strategy, including risk assessment, mitigation planning, gap closure, and sustainable implementation across manufacturing sites.\n\nServe as a global subject matter expert and strategic leader for contamination control and aseptic manufacturing practices.\n\nRisk Management and Site Support\nLead global sterility assurance risk assessments and support sites in responding to contamination events, sterility failures, microbiological excursions, and adverse trends.\n\nFacilitate root cause investigations and implement effective corrective and preventive actions (CAPAs) across the network.\n\nPromote cross-site collaboration, knowledge sharing, and implementation of best practices.\n\nNetwork Standardization and Continuous Improvement\nDrive harmonization of sterility assurance standards and contamination control programs across global sites.\n\nEstablish and improve procedures governing facility and equipment design, process design, material transfer, environmental monitoring, microbiological testing, maintenance, cleaning, disinfection, and segregation controls.\n\nChampion continuous improvement initiatives that strengthen contamination control, consistency, and inspection readiness.\n\nNew Product Introduction and Technical Expertise\nAct as the global sterility assurance expert for product development, technology transfer, and new product introductions.\n\nEnsure phase-appropriate sterility assurance practices are embedded throughout development and commercial manufacturing programs.\n\nSupport network expansion projects and new facility start-ups as required.\n\nCapability Building and Regulatory Support\nCoach and train employees to strengthen understanding of biological risks, contamination control, and aseptic behaviors.\n\nSupport regulatory inspections, customer audits, GQC audits, mock pre-approval inspections, due diligence activities, and other compliance initiatives as a sterility assurance SME.\n\nMonitor evolving industry and regulatory expectations and ensure timely implementation across the network.\n\nWhat You'll Bring\nEducation\nBachelor's, Master's, or higher degree in Microbiology, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, or a related scientific discipline.\n\nAdvanced scientific qualifications or certifications are advantageous.\n\nExperience\nSignificant leadership experience within sterile pharmaceutical, biotechnology, biologics, cell and gene therapy, or related GMP-regulated environments.\n\nDeep expertise in sterility assurance, contamination control, microbiology, aseptic processing, and quality risk management.\n\nDemonstrated experience supporting complex investigations, contamination events, and regulatory inspections.\n\nProven success influencing and leading within global, matrixed organizations.\n\nSkills\nExpert knowledge of sterile manufacturing regulations and industry standards.\n\nStrong understanding of contamination control strategies and microbiological risk assessment.\n\nExcellent communication, coaching, and stakeholder management skills.\n\nAbility to drive global alignment while balancing site-specific operational needs.\n\nContinuous improvement mindset with a passion for scientific excellence and operational effectiveness.\n\nEvery Day, Lonza's Products and Services Have a Positive Impact\nAt Lonza, you will join a purpose-driven organization where your expertise contributes directly to the development and manufacture of therapies that improve and save lives worldwide. We foster a culture of innovation, collaboration, and continuous learning, providing opportunities to make a meaningful impact on a global scale.\nEvery day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a privilege, but a responsibility we take seriously.\nApply today and help shape the future of sterility assurance across Lonza's global manufacturing network.","description_format":"text","description_chars":4946,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-19T03:51:56Z"}],"visa":[],"liveness":{"score":46,"band":"ok","label":"Likely open","p_open":1,"p_active":0.612,"p_room":0.75,"age_days":31,"expected_fill_days":34,"reasons":["conf:27","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/lonza-director-sterility-assurance","json_url":"https://alion.io/job/lonza-director-sterility-assurance.json","meta":{"generated_at":"2026-10-26T02:46:44Z","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":3637,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":679681},"rest":"https://alion.io/mcp/rest/get_company?id=679681"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flonza-director-sterility-assurance"},{"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%2Flonza-director-sterility-assurance"},{"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%2Flonza-director-sterility-assurance"},{"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/lonza-director-sterility-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flonza-director-sterility-assurance"}]}