CQV Manager

Legend Biotech US • Raritan, NJ

3d • $127,313 - $167,099 • Onsite

About The Position

Legend Biotech is seeking a CQV Manager for its Technical Operations team in Raritan, New Jersey. The role leads and oversees Commissioning, Qualification, and Validation (CQV) and Computerized Systems Validation (CSV) activities supporting a cGMP clinical and commercial cell therapy manufacturing facility. It provides technical leadership and operational oversight for the commissioning, qualification, requalification, and validation of facilities, utilities, equipment, computerized systems, and manufacturing processes used in personalized cell therapy operations.

The manager is accountable for planning, executing, and maintaining lifecycle qualification and validation programs so systems remain compliant, fit for intended use, and in a validated state. The role includes protocol development and execution, vendor and contractor management, investigations, CAPAs, change control, remediation, and validation documentation in accordance with regulatory requirements and industry practices. It represents CQV and CSV during audits, regulatory inspections, and inspection-readiness activities, collaborating with Engineering, Manufacturing, Facilities, Quality, Validation, Automation, Information Technology, and other teams to establish and sustain a robust, risk-based CQV program.

Requirements

• Bachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or a related technical discipline.
• At least 8 years of progressive experience in CQV and CSV, Quality, Engineering, Manufacturing, or Compliance in a regulated pharmaceutical, biotechnology, cell therapy, or medical device environment.
• At least 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.
• Extensive knowledge of cGMP, cGTP, and global regulatory requirements, including FDA regulations, EU GMP Annex 11 and Annex 15, GAMP 5, and applicable ICH guidelines.
• Strong understanding of GMP data integrity principles and regulatory expectations.
• Working knowledge of regulations and guidance for cell and gene therapy products, including tissue-based and cellular therapies.
• Experience supporting internal audits and remediation activities.
• Proven experience leading commissioning, qualification, requalification, and validation 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 VMPs, Project Validation Plans, risk assessments and FMEAs, IQ/OQ/PQ protocols, summary reports, technical impact assessments, SOPs, work instructions, change controls, and addenda.
• Strong project management skills and ability to manage multiple priorities, deadlines, and cross-functional initiatives simultaneously.
• Ability to work independently, lead teams, and influence stakeholders across organizational levels.
• Skill in root cause analysis, investigation management, CAPA development, and continuous improvement.
• Experience applying operational excellence, risk-based validation, and process improvement methodologies.
• Excellent written, verbal, and interpersonal communication skills, including clear communication of complex technical information.
• Strong presentation and technical writing skills, including summarizing data, presenting findings, and supporting decision-making.
• Ability to build collaborative relationships and work effectively with cross-functional and multidisciplinary teams.
• Highly organized and detail-oriented, with sound decision-making in a fast-paced 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.
• English language proficiency.
• Applicants must be authorized to work in the United States.

Nice To Haves

• Advanced degree or relevant professional certifications.
• Experience in aseptic manufacturing environments.
• Direct experience in cell therapy, CAR-T, biologics, tissue processing, quality assurance, or manufacturing compliance.
• Familiarity with electronic validation systems, quality management systems, and computerized system lifecycle management.

Responsibilities

• Serve as the CQV subject matter expert for applicable global regulatory requirements and industry standards, including 21 CFR Parts 11, 210, and 211, EU GMP Annex 11 and Annex 15, GAMP 5, and current validation practices.
• Partner with cross-functional teams to implement, standardize, and maintain site CQV tools, procedures, policies, and compliance strategies.
• Lead and supervise commissioning, qualification, requalification, and validation of manufacturing and laboratory equipment, computerized systems, automation platforms, process equipment, utilities, and facilities.
• Manage concurrent CQV and CSV projects and initiatives in alignment with timelines, site objectives, regulatory expectations, and business priorities.
• Coordinate project execution with internal teams and external vendors and contractors.
• Lead and support quality and technical investigations, including deviations, nonconformances, root cause analyses, CAPAs, and remediation activities.
• Develop, implement, and monitor remediation plans addressing compliance gaps, inspection observations, and system improvements.
• Author, review, approve, and execute validation lifecycle documentation, including validation plans, protocols, reports, periodic reviews, and traceability documentation.
• Assess, initiate, review, and approve change controls; ensure impact assessments, qualification requirements, and validation deliverables are identified and completed.
• Participate in developing and executing risk assessments, FMEAs, Validation Master Plans, project plans, periodic qualification programs, and Annual Product Reviews.
• Administer and maintain the site Qualification and Requalification Program to sustain the validated status of GMP systems and equipment.
• Represent CQV and CSV during internal audits, customer audits, and regulatory inspections; lead or support timely resolution of observations and commitments.
• Drive continuous improvement in validation effectiveness, compliance, standardization, and operational efficiency using risk-based and science-based approaches.
• Provide technical guidance, coaching, and mentorship to CQV personnel and cross-functional stakeholders.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan with company match that vests fully on day one
• Eight weeks of paid parental leave after three months of employment
• Paid time off including vacation, personal time, sick time, floating holidays, and eleven company holidays
• Flexible spending accounts and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs
• Performance-based bonus and/or equity for eligible employees

What This Job Offers

• Job Type: Full-time
• Career Level: Senior