{"id":2902160,"url":"https://alion.io/job/lonza-lead-specialist-qa","title":"Lead Specialist, (QA)","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":36,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-10-21T05:46:15Z"}},"role":"QA","role_family":"QA","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Singapore"],"countries":["SG"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-06-08T00:00:00Z","employer_posted_date":"2026-06-08","last_verified_at":"2026-10-21T21:00:45Z","board_verified":true,"closed_at":null,"days_open":136,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":135},"description":"Location: Tuas, Singapore\nBe part of Lonza’s Quality Assurance team, where you will play a key role in ensuring compliance, quality oversight, and continuous improvement across a multi-product cGxP contract manufacturing facility. As a Lead Specialist, QA, you will provide technical leadership and quality guidance across Quality Systems, Validation & Technical Compliance, Quality Compliance, Quality Operations, or Customer Projects. This role requires strong quality expertise, sound decision-making, and the ability to lead complex investigations, support audits and inspections, and drive cross-functional quality initiatives that ensure product quality, patient safety, and regulatory compliance.\nWhat you will get\nAn agile career and dynamic working culture.\nAn inclusive and ethical workplace.\nCompensation programs that recognize high performance.\nOpportunities to collaborate with global cross-functional teams.\nOngoing learning and professional development opportunities.\nOur full list of global benefits can be found here: Lonza Benefits.\nWhat you will do\nProvide Quality Assurance oversight for manufacturing, laboratory, validation, technical compliance, quality systems, and customer project activities, ensuring compliance with cGMP requirements and Lonza quality standards.\nLead and support complex quality events including deviations, CAPAs, change controls, customer complaints, investigations, and risk assessments using structured root cause analysis methodologies.\nReview and approve quality documentation including SOPs, protocols, reports, batch records, validation documents, TrackWise records, and other GMP documentation to ensure accuracy and compliance.\nSupport and represent QA during regulatory inspections, customer audits, and supplier audits, acting as a subject matter expert and ensuring inspection readiness at all times.\nDrive cross-functional quality improvement initiatives, technical projects, and operational excellence programs while providing guidance and mentorship to junior team members.\nProvide quality oversight for product disposition, manufacturing operations, validation activities, customer projects, and quality system processes, ensuring timely execution and risk-based decision making.\nPromote a strong culture of quality, data integrity, compliance, and continuous improvement while building effective relationships with internal and external stakeholders.\nWhat we are looking for\nDegree in Science, Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline.\nExperience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, cell therapy, biologics, or contract manufacturing environment.\nStrong knowledge of cGMP requirements, quality systems, validation, technical compliance, deviation management, CAPA, change control, and regulatory expectations.\nExperience supporting regulatory inspections, customer audits, supplier audits, and quality management system activities.\nDemonstrated ability to lead complex investigations, assess quality risks, make sound quality decisions, and drive issue resolution across cross-functional teams.\nStrong communication, stakeholder management, project leadership, and coaching skills with the ability to influence decisions at multiple organizational levels.\nExperience with electronic Quality Management Systems (eQMS), TrackWise, data integrity principles, and GMP documentation management is preferred.\nAbout Lonza\nAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.\nInnovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.\nReady to shape the future of life sciences? Apply now.","description_format":"text","description_chars":4300,"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":["Professional development"],"hiring_locations":[{"name":"Singapore","iso":"SG","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-20T06:49:48Z"}],"visa":[],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.182,"p_room":0.28,"age_days":135,"expected_fill_days":11,"reasons":["conf:0","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/lonza-lead-specialist-qa","json_url":"https://alion.io/job/lonza-lead-specialist-qa.json","meta":{"generated_at":"2026-10-22T00:23:22Z","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":537,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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-lead-specialist-qa"},{"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-lead-specialist-qa"},{"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-lead-specialist-qa"},{"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-lead-specialist-qa\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flonza-lead-specialist-qa"}]}