CQV Manager

BioSpace; 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

Paid parental leave

Vacation and PTO

Job summary

Legend Biotech, based in Raritan, NJ, seeks a CQV Manager to lead commissioning, qualification, and validation for a cell therapy manufacturing facility. You will guide CQV/CSV programs across facilities, utilities, equipment, and computerized systems to ensure compliant, validated operations and reliable production of therapies.

This role requires deep regulatory knowledge (FDA, EU GMP) and strong leadership to mentor teams, manage audits, and drive remediation of findings while maintaining a

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field is required.
• Advanced degrees or professional certifications are preferred.
• Minimum 8 years of CQV/CSV or related experience in regulated environments.
• Minimum 5 years of leadership experience in cross-functional settings.
• Experience with FDA/global regulatory requirements and GMP is essential.

Responsibilities

• Serve as SME for CQV/CSV per global regulatory requirements.
• Lead and supervise CQV/CSV activities for equipment and systems.
• Coordinate cross-functional teams to ensure timely project execution.
• Manage regulatory audits, deviations, CAPAs, and change controls.
• Develop validation plans, protocols, reports, and lifecycle docs.

Skills

CQV/CSV leadership

Regulatory compliance

Process validation

Cross-functional collaboration

Project management

Education

Bachelor’s degree in engineering or life sciences

Advanced degrees preferred

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Microsoft Excel

Office Suite

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.

Language Requirements: English.

Pay Range (Base Pay)

• $127,313 - $167,099 USD

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off

• 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.

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.

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