Sr. CQV Specialist

Legend Biotech is seeking a Sr. CQV Specialist as part of the Technical Operations team based in Raritan, NJ
. Role Overview

This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The individual will handle day-to-day activities including execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes, supporting personalized cell therapy production through safe and compliant manufacturing operations in accordance with cGMP requirements.

The role will require CQV experience, represent CQV work in regulator and internal audits, and work independently while driving effective communication and collaboration across cross-functional groups to establish a robust CQV program and enable robust production, testing and release of product to patients.

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaborates with cross-functional teams, provides status reports and coordinates with other departments or external contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Trains and supports junior team members on different CQV activities.
• Present CQV work to regulatory and internal audit teams.
• Other responsibilities as assigned.

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline.
• A minimum of 7 years relevant work experience, preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance or manufacturing compliance.
• Experience with Microsoft suite & ERP systems (Maximo, Siemens EMS, Comet, Kneat) and testing systems (Kaye AVS, Kaye Valprobe).
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products and Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to process complex information quickly and make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently manage a portfolio of ongoing projects.
• Attention to detail and adherence to procedures.
• Highly organized, positive attitude, and ability to work in a team environment.
• Detailed knowledge of cGMP and cGTP related to CAR‑T manufacturing or cell processing.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271, 600, 601, 610.
• Experience authoring and executing documentation (Batch Records, SOPs, Work Instructions, CQV protocols).

Benefits include medical, dental, and vision insurance, 401(k) with company match, eight weeks of paid parental leave after three months, paid time off (vacation, personal, sick, floating holidays), 11 company holidays, flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability, legal assistance, supplemental plans, commuter benefits, and peer-to-peer recognition programs. These benefits are exclusive to permanent full-time employees.

Legend Biotech provides equal employment opportunities without regard to race, color, creed, religion, national origin, citizenship status, age, sex, gender identity, sexual orientation, marital status, military service, veteran status, disability, genetic information, or any other protected characteristic under applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice. The company may adjust base salary or other compensation at any time based on individual, team, performance, or market conditions.