{"id":1402234,"url":"https://alion.io/job/legend-biotech-cqv-supervisor-2","title":"CQV Supervisor","company":{"id":12179,"name":"Legend Biotech","domain":"legendbiotech.com","url":"https://alion.io/company/legend-biotech","size_band":"501-1000","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":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Raritan, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":110706,"max":145303,"currency":"USD","period":"year","gross":null,"usd_annual":145303},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Matter","optional":false},{"name":"Microsoft Office","optional":true},{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-09-28T15:28:11Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-02T15:10:08Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.\nLegend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.\nRole Overview:\n The Commissioning, Qualification, and Validation (CQV) Supervisor is responsible for leading and overseeing CQV activities supporting a cGMP clinical and commercial cell therapy manufacturing facility. This role provides technical leadership and operational oversight for the commissioning, qualification, requalification, and validation of facilities, utilities, equipment, computerized systems, and manufacturing processes critical to personalized cell therapy operations.\nThe CQV Supervisor is accountable for the planning, execution, and lifecycle management of qualification and validation programs to ensure systems remain compliant, fit for intended use, and maintained in a validated state throughout their operational lifecycle. Responsibilities include protocol development and execution, vendor and contractor management, deviation investigations, CAPA implementation, change control support, remediation initiatives, and maintenance of validation documentation in accordance with regulatory requirements and industry best practices.\nAs a key member of the site's quality and compliance framework, this position serves as a primary CQV representative during internal audits, regulatory inspections, and inspection-readiness activities. The role requires strong technical expertise, leadership, and the ability to collaborate effectively across Engineering, Manufacturing, Facilities, Quality, Validation, Automation, Information Technology, and other cross-functional teams to establish and sustain a robust, risk-based CQV program. Through these efforts, the CQV Supervisor helps ensure reliable manufacturing operations and consistent production, testing, and release of safe, effective, and high-quality cell therapy products for patients.\nMajor Responsibilities: \nServe as the Commissioning, Qualification, and Validation Subject Matter Expert (SME) for applicable global regulatory requirements and industry standards, including 21 CFR Parts 11, 210, and 211, EU GMP Annex 11, Annex 15, GAMP 5 and current validation best practices.\nPartner with cross functional teams to implement, standardize, and maintain CQV tools, procedures, policies, and compliance strategies across the site.\nLead and supervise commissioning, qualification, requalification, and validation activities for manufacturing and laboratory equipment, computerized systems, automation platforms,, process equipment, utilities, facilities.\nManage multiple concurrent CQV projects and initiatives, ensuring alignment with project timelines, site objectives, regulatory expectations, and business priorities.\nCoordinate activities with Engineering, Manufacturing, Quality, Facilities, Automation, Information Technology, and external vendors and contractors to ensure successful project execution.\nLead and support quality and technical investigations, including deviations, nonconformances, root cause analyses, corrective actions, preventive actions (CAPAs), and remediation activities.\nDevelop, implement, and monitor remediation plans to address compliance gaps, inspection observations, and system improvements while ensuring sustainable effectiveness.\nAuthor, review, approve, and execute validation lifecycle documentation, including validation plans, protocols, reports, periodic reviews, and traceability documentation, ensuring compliance with regulatory requirements, company procedures, and data integrity principles.\nAssess, initiate, review, and approve change controls, ensure appropriate impact assessments, qualification requirements, and validation deliverables are identified and completed.\nParticipate in the development and execution of risk assessments, FMEAs, Validation Master Plans (VMPs), project plans, periodic qualification programs, and Annual Product Reviews.\nAdminister and maintain the site Qualification and Requalification Program to ensure continued validated status of GMP systems and equipment.\nRepresent the CQV function during internal audits, customer audits, and regulatory inspections, and lead or support the timely resolution of audit observations and inspection commitments.\nDrive continuous improvement initiatives to enhance validation effectiveness, compliance, standardization, and operational efficiency through risk-based and science-based approaches.\nProvide technical guidance, coaching, and mentorship to CQV personnel and cross-functional stakeholders to promote a culture of quality, compliance, and inspection readiness.\nEducation\nBachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline is required.\nAdvanced degrees or relevant professional certifications are preferred.\nExperience\nMinimum of 8 years of progressive experience in Commissioning, Qualification, Validation (CQV), Quality, Engineering, Manufacturing, or Compliance within a regulated pharmaceutical, biotechnology, cell therapy, or medical device environment.\nPreferred up to 3 years of leadership or supervisory experience, including management of personnel, projects, contractors, and cross-functional teams.\nDemonstrated expertise in FDA and global regulatory requirements, including 21 CFR Parts 11, 58, 210, 211, and 1271, EU GMP regulations, EudraLex, and applicable ICH guidelines.\nExperience supporting regulatory inspections, audits, validation programs, investigations, CAPAs, change controls, and lifecycle management of GMP systems.\nExperience in aseptic manufacturing environments is highly preferred, with direct experience in cell therapy, CAR-T, biologics, tissue processing, quality assurance, or manufacturing compliance highly desirable.\nSkills & Competencies\nRegulatory Compliance & Quality Systems\nExtensive knowledge of cGMP, cGTP, and global regulatory requirements, including FDA regulations, 21 CFR Parts 11, 210, 211, 1271, EU GMP Annex 11, Annex 15, GAMP 5 and applicable ICH guidelines.\nStrong understanding of GMP Data Integrity principles and regulatory expectations.\nWorking knowledge of regulations and guidance related to the manufacture of cell and gene therapy products, including tissue-based and cellular therapies.\nExperience supporting regulatory inspections, internal audits, and remediation activities.\nCQV & Technical Expertise\nProven experience leading commissioning, qualification, requalification, and validation activities for facilities, utilities, manufacturing equipment, laboratory systems, computerized systems, and automation platforms.\nAbility to identify compliance risks, evaluate system impacts, and develop effective remediation strategies.\nExperience authoring, reviewing, approving, and executing validation lifecycle documentation, including:\nValidation Master Plans (VMPs)\nProject Validation Plans (PVPs)\nRisk Assessments and FMEAs\nIQ/OQ/PQ Protocols\nSummary Reports\nTechnical Impact Assessments\nSOPs and Work Instructions\nChange Controls and Addenda\nLeadership & Project Management\nStrong project management skills with the ability to manage multiple priorities, deadlines, and cross-functional initiatives simultaneously.\nDemonstrated ability to work independently while effectively leading teams and influencing stakeholders across all organizational levels.Skilled in root cause analysis, investigation management, CAPA development, and continuous improvement initiatives.\nExperience applying operational excellence, risk-based validation, and process improvement methodologies.\nCommunication & Collaboration\nExcellent written, verbal, and interpersonal communication skills with the ability to communicate complex technical information clearly and effectively.\nStrong presentation and technical writing skills, including the ability to summarize data, present findings, and support decision-making.\nProven ability to build collaborative relationships and work effectively within cross-functional and multidisciplinary teams.\nHighly organized, detail-oriented, and capable of making sound decisions in a fast-paced and dynamic environment.\nSystems & Software\nExperience with validation and maintenance systems such as Maximo, Siemens EMS, Comet, Kneat, Summit, or equivalent platforms.\nProficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.\nFamiliarity with electronic validation systems, quality management systems (QMS), and computerized system lifecycle management is preferred.\n\nThe base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.\nOther Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.\nBenefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.\nPay Range (Base Pay):\n$110,706—$145,303 USD\nPlease note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.\nWork Authorization & Employment Eligibility\nApplicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.\nEEO Statement\nIt is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service an...","description_format":"text","description_chars":12362,"description_truncated":true,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-28T16:11:42Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":3,"expected_fill_days":57,"reasons":["conf:4","win:early"],"computed_at":"2026-10-02T05:45:00Z"},"pay":{"stated_usd_annual":145303,"is_top_pay":true},"html_url":"https://alion.io/job/legend-biotech-cqv-supervisor-2","json_url":"https://alion.io/job/legend-biotech-cqv-supervisor-2.json","meta":{"generated_at":"2026-10-03T00:52:27Z","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":612,"day_limit":5000,"remaining_today":4388,"minute_limit":60,"resets_at":"2026-10-04T00:00:00Z"}}}