CQV Manager

Legend Biotech US; Raritan (NJ); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

8 weeks paid parental leave

Job summary

Legend Biotech US is seeking a CQV Manager to lead commissioning, qualification, and validation activities for a cutting-edge cell therapy manufacturing facility in Raritan, NJ. You will provide technical leadership, ensure regulatory compliance, and oversee validation of facilities, utilities, equipment, and computerized systems.

The role requires 8+ years in CQV/CSV, strong leadership, and deep knowledge of FDA/EU regulations.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Minimum of 8 years CQV/CSV, Quality, Engineering, or Compliance experience in regulated environment.
• Minimum 5 years of leadership or supervisory experience with cross-functional teams.
• Demonstrated expertise in FDA/global regulatory requirements and audits (21 CFR parts 11, 58, 210, 211, 1271; EU GMP).

Responsibilities

• Serve as SME for CQV/CSV per global regulatory standards (21 CFR, EU GMP).
• Lead CQV/CSV projects, timelines, and cross-functional collaboration across Engineering, Manufacturing, Quality, Facilities, IT.
• Author, review, and execute validation lifecycle docs (VMPs, IQ/OQ/PQ, SOPs).
• Manage deviations, CAPAs, change controls, and risk-based remediation plans.
• Represent CQV/CSV in internal and regulatory audits; drive inspection readiness.
• Mentor CQV staff and drive continuous improvement of validation programs.

Skills

CQV/CSV expertise

Regulatory compliance

FDA 21 CFR familiarity

CAPA management

Change controls

Risk assessments

Project management

Documentation skills

Data integrity

Validation systems tools

MS Office / Teams

Education

Bachelor’s degree in Engineering

Advanced degree or certifications (preferred)

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Microsoft Office (Word/Excel/PowerPoint/Outlook/Teams)

Job 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.

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 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.

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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.

Other Types of Pay:

Performance-based bonus and/or equity is available to employees in eligible roles.

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.

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Legend Biotech US’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.