CQV Manager

The role

The CQV Manager leads and oversees CQV and CSV activities for a cGMP clinical and commercial cell therapy manufacturing facility. This role provides technical leadership for the qualification and validation of facilities, utilities, equipment, computerized systems, and manufacturing processes.

What you will do

• Serve as the CQV Subject Matter Expert for global regulatory requirements and industry standards
• Partner with cross functional teams to implement and maintain CQV tools and procedures
• Lead and supervise commissioning, qualification, and validation activities
• Manage multiple concurrent CQV and CSV projects
• Coordinate activities with Engineering, Manufacturing, Quality, and other departments
• Lead and support quality and technical investigations including deviations and CAPAs
• Develop and monitor remediation plans to address compliance gaps
• Author, review, approve, and execute validation lifecycle documentation
• Assess, initiate, review, and approve change controls
• Participate in the development of risk assessments and Validation Master Plans

Required qualifications

• Bachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline
• Minimum of 8 years of progressive experience in CQV & CSV, Quality, Engineering, Manufacturing, or Compliance within a regulated pharmaceutical, biotechnology, cell therapy, or medical device environm
• Minimum of 5 years of leadership or supervisory experience
• Demonstrated expertise in FDA and global regulatory requirements including 21 CFR Parts 11, 58, 210, 211, and 1271, EU GMP regulations, EudraLex, and ICH guidelines
• Experience supporting regulatory inspections, audits, validation programs, investigations, CAPAs, and change controls
• Extensive knowledge of cGMP, cGTP, and global regulatory requirements
• Strong understanding of GMP Data Integrity principles
• Working knowledge of regulations related to the manufacture of cell and gene therapy products
• Experience leading commissioning, qualification, and validation for facilities, utilities, equipment, and computerized systems
• Experience authoring and executing validation documentation like VMPs, IQ/OQ/PQ, and SOPs
• Experience with validation and maintenance systems such as Maximo, Siemens EMS, Comet, Kneat, or Summit
• Proficiency with Microsoft Office applications

Nice to have

• Advanced degrees 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 (QMS), and computerized system lifecycle management

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight weeks of paid parental leave after three months of employment
• Vacation time
• Personal time
• Sick time
• Floating holidays
• Eleven company holidays
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance

Before you apply

• Applicants must be authorized to work in the United States
• Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. The company is advancing the next generation of cell therapy through a portfolio of innovative technologies.