CQV Manager

legendcareers; Raritan (NJ); In loco; USD 130.000 - 190.000; Tempo pieno

Descrizione del lavoro

Legend Biotech is seeking a CQV Manager in Raritan, NJ to lead commissioning, qualification, and validation activities for a cGMP cell therapy manufacturing facility. The role provides technical leadership and oversight of CQV/CSV programs, ensuring systems stay validated, compliant and fit for use throughout the lifecycle.

The candidate will collaborate with Engineering, Manufacturing, Quality, Facilities, Automation, IT and external vendors to drive CQV excellence, manage deviations and CAPAs,

Competenze

• CQV/CSV subject-matter expertise required (cGMP environments).
• Experience with 21 CFR Parts 11, 210, 211 and EU GMP guidelines preferred.
• Strong leadership of cross-functional teams across Engineering, Manufacturing, Quality, Facilities, Automation and IT.

Mansioni

• Lead CQV/CSV activities for facilities, utilities, equipment, and computerized systems.
• Develop and execute qualification/validation plans and lifecycle documentation.
• Manage vendor/contractor relationships, deviations, CAPAs, and change controls.
• Ensure regulatory inspections readiness and robust risk-based CQV program.

Conoscenze

CQV SME

Regulatory standards

Cross-functional leadership

GAMP 5

Descrizione del lavoro

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.

Legend 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.

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 Revi