Legend Biotech is seeking a CQV Manager as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Commissioning, Qualification, and Validation (CQV & CSV) Manager is responsible for leading and overseeing CQV & CSV 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.The CQV & CSV Validation Manager 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.As a key member of the site's quality and compliance framework, this position serves as a primary CQV & CSV 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 & CSV Validation helps ensure reliable manufacturing operations and consistent production, testing, and release of safe, effective, and high-quality cell therapy products for patients.

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.

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