{"id":1485699,"url":"https://alion.io/job/meiragtx-senior-qa-associate","title":"Senior QA Associate","company":{"id":3192810,"name":"MeiraGTx","domain":"meiragtx.com","url":"https://alion.io/company/meiragtx","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Personio","truth_index":null},"role":"QA","role_family":"QA","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["London, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":59000,"max_usd":114000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":11},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-29T12:21:29Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-09-29T23:07:40Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Your mission\nProvide experienced QA support and oversight to MeiraGTx operations.\nEnsure QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner. \nCoach and train the QA team and other functions and continuously improve the local Quality system and provide training & support for Quality relevant systems. \nJob Description\nMajor Activities and Responsibilities:\nProvide QA oversight to the manufacturing operation and supporting functions.\nManagement of the MeiraGTx Quality Management System.\nGeneration, Review and approval of relevant GMP documentation. \nCreate and Review QA Processes. Create/review Standard Operating Procedures, Policies and Training material.\nMaintain QA KPI metrics.\nCollaborate with Operational areas, supporting the Team Lead to manage the day-to-day QA Operations.\nReview Batch documentation and support QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.\nManage and support QA team Facility Walk rounds and QA support for all operational areas.\nProvide direct quality team support during customer and regulatory audits.\nPerform internal audits and inspections and audit write up.\nQuality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality Risk Assessments, Incidents, Deviations, CAPA’s, OOS, Change Controls and temperature excursions.\nSupport Document Management activities when required.\nProactively initiate and support continuous improvement of the Quality Management System.\nDeliver compliance training to operational areas.\nProvide guidance and assistance to quality related issues in Operational areas and to External third parties.\nDeputise for the QA Team Leader - Operations when required.\nProactive individual, able to step in without being asked. Identifies upcoming activities or tasks and works on completion without the need to be asked.\nCollaboration and stakeholder management.\nAdaptability ad resilience.\nSupports innovation by challenging outdated practices and encouraging better ways of working.\nAlways asks and understands the “why” and is capable of explaining this to others. Does not automatically accept the status quo.\nFinds better ways for completing existing activities/processes saving time or effort while remaining compliant.\nData driven decision making. Able to check reliability of sources, identify gaps, inconsistencies or misleading information.\nDemonstrates critical thinking and logical reasoning.\nKey Job Competencies and Behaviours\nMinimum 5 years experience of working within a sterile GMP manufacturing environment.\nExcellent understanding of Quality Management Systems.\nDemonstrate very good understanding of the purpose of the regulation requirements in terms of how they translate to product quality and patient safety.\nProficient in Microsoft Office and experience in database use and eQMS systems.\nExcellent interpersonal skills. Role model for professional behaviours, respectful relationships, positive and constructive communication.\nCapable of demonstrating structured thinking, data gathering and analysis for informed decisions.\nGood organisational and time management skills and able to demonstrate flexibility and adaptability. Capable of consistent on-time delivery of their individual tasks and responsibilities. Able to prioritise workload, decisive thinker able to work within agreed timescales.\nA high level of attention to detail.\nGood team player and must also be able to work independently.\nStrong experience in Regulatory inspections and Client audits.\nJob Background\nExperience working in a Sterile manufacturing GMP environment including a minimum 5 years’ experience in Compliance and Quality Assurance.\nIT literate, experience managing and operating an electronic QMS.\nExcellent verbal and written communication skills.","description_format":"text","description_chars":3957,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care"],"lifecycle":[{"event":"open","at":"2026-09-29T23:07:40Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":46,"reasons":["conf:6","win:early"],"computed_at":"2026-09-30T05:14:31Z"},"pay":null,"html_url":"https://alion.io/job/meiragtx-senior-qa-associate","json_url":"https://alion.io/job/meiragtx-senior-qa-associate.json","meta":{"generated_at":"2026-09-30T05:14:31Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":3627,"day_limit":5000,"remaining_today":1373,"minute_limit":60,"resets_at":"2026-10-01T00:00:00Z"}}}