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CQV Manager

Legend Biotech US
Raritan, USA
Manager · 8+ years experience
Onsite
USD 127313-167099 / year
Discovered Today

Full Job Posting

Key Responsibilities

  • Serve 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.
  • Partner with cross functional teams to implement, standardize, and maintain CQV tools, procedures, policies, and compliance strategies across the site.
  • Lead and supervise commissioning, qualification, requalification, and validation activities for manufacturing and laboratory equipment, computerized systems, automation platforms,, process equipment, utilities, facilities.
  • Manage multiple concurrent CQV & CSV projects and initiatives, ensuring alignment with project timelines, site objectives, regulatory expectations, and business priorities.
  • Coordinate activities with Engineering, Manufacturing, Quality, Facilities, Automation, Information Technology, and external vendors and contractors to ensure successful project execution.
  • Lead and support quality and technical investigations, including deviations, nonconformances, root cause analyses, corrective actions, preventive actions (CAPAs), and remediation activities.
  • Develop, implement, and monitor remediation plans to address compliance gaps, inspection observations, and system improvements while ensuring sustainable effectiveness.
  • Author, 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.
  • Assess, initiate, review, and approve change controls, ensure appropriate impact assessments, qualification requirements, and validation deliverables are identified and completed.
  • Participate in the development and execution of risk assessments, FMEAs, Validation Master Plans (VMPs), project plans, periodic qualification programs, and Annual Product Reviews.
  • Administer and maintain the site Qualification and Requalification Program to ensure continued validated status of GMP systems and equipment.
  • Represent the CQV & CSV function during internal audits, customer audits, and regulatory inspections, and lead or support the timely resolution of audit observations and inspection commitments.
  • Drive continuous improvement initiatives to enhance validation effectiveness, compliance, standardization, and operational efficiency through risk-based and science-based approaches.
  • Provide technical guidance, coaching, and mentorship to CQV personnel and cross-functional stakeholders to promote a culture of quality, compliance, and inspection readiness.

Requirements

  • Bachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline is required.
  • Advanced degrees or relevant professional certifications are preferred.
  • Minimum of 8 years of progressive experience in Commissioning, Qualification, Validation (CQV & CSV), Quality, Engineering, Manufacturing, or Compliance within a regulated pharmaceutical, biotechnology, cell therapy, or medical device environment.
  • Minimum of 5 years of leadership or supervisory experience, including management of personnel, projects, contractors, and cross-functional teams.
  • Demonstrated 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.
  • Experience supporting regulatory inspections, audits, validation programs, investigations, CAPAs, change controls, and lifecycle management of GMP systems.
  • Experience 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.
  • Extensive 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.
  • Strong understanding of GMP Data Integrity principles and regulatory expectations.
  • Working knowledge of regulations and guidance related to the manufacture of cell and gene therapy products, including tissue-based and cellular therapies.
  • Experience supporting regulatory inspections, internal audits, and remediation activities.
  • Proven experience leading commissioning, qualification, requalification, and validation activities for facilities, utilities, manufacturing equipment, laboratory systems, computerized systems, and automation platforms.
  • Ability to identify compliance risks, evaluate system impacts, and develop effective remediation strategies.
  • Experience authoring, reviewing, approving, and executing validation lifecycle documentation, including:
  • Validation Master Plans (VMPs)
  • Project Validation Plans (PVPs)
  • Risk Assessments and FMEAs
  • IQ/OQ/PQ Protocols
  • Summary Reports
  • Technical Impact Assessments
  • SOPs and Work Instructions
  • Change Controls and Addenda
  • Strong project management skills with the ability to manage multiple priorities, deadlines, and cross-functional initiatives simultaneously.
  • Demonstrated 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.
  • Experience applying operational excellence, risk-based validation, and process improvement methodologies.
  • Excellent written, verbal, and interpersonal communication skills with the ability to communicate complex technical information clearly and effectively.
  • Strong presentation and technical writing skills, including the ability to summarize data, present findings, and support decision-making.
  • Proven ability to build collaborative relationships and work effectively within cross-functional and multidisciplinary teams.
  • Highly organized, detail-oriented, and capable of making sound decisions in a fast-paced and dynamic environment.
  • Experience with validation and maintenance systems such as Maximo, Siemens EMS, Comet, Kneat, Summit, or equivalent platforms.
  • Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
  • Familiarity with electronic validation systems, quality management systems (QMS), and computerized system lifecycle management is preferred.
  • Language Requirements: English.
  • #Li-RN1
  • #Li-Onsite
  • The 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.
  • Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
  • Benefits 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.
  • Pay Range (Base Pay): $127,313—$167,099 USD
  • Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
  • Work Authorization & Employment Eligibility
  • Applicants 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.
  • EEO Statement
  • It 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 and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
  • Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
  • For information related to our privacy notice, please review: Legend Biotech Privacy Notice.

Preferred Qualifications

  • Advanced degrees or relevant professional certifications are preferred.
  • Experience 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.
  • Familiarity with electronic validation systems, quality management systems (QMS), and computerized system lifecycle management is preferred.
  • Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

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