Description

Legend Biotech is seeking Principal QA Validation Specialist as part of the Quality team based in Raritan, NJ.

Role Overview

The Principal QA Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for facility, equipment, systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for reviewing and approving, work orders, qualification protocols, and reports in support of equipment and facility qualification, process validation, maintenance activities, and data integrity for computerized systems.

Key Responsibilities

• Provide quality and compliance oversight for the qualification, validation, process and equipment and facilities maintenance activities within the manufacturing and testing plant.
• Ability to manage multiple and complex validation projects, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks with minimal oversight.
• Support technical, quality, and quality control investigations.
• Collaborates with functional departments to resolve issues.
• Manages cross-functional projects with many stakeholders.
• Review and approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, Specifications, and other applicable acceptance criteria.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Review and approve change controls, SOPs, and other documentation.
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues or data trends. Seek management guidance on complex issues.
• Drive continuous improvement.
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Provide guidance to junior QAV employees.
• Provide resolution and solutions for quality issues

Requirements

• A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required.
• A minimum of 8+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceutical. Experience in supporting cell-based products as well as knowledge of Good Tissue Practices is a plus.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information with minimal oversight.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing, complex projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP). Knowledge of current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing is a plus.
• Ability to identify/remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610, and GAMP is preferred.
• Experience reviewing/auditing GMP documentation including but not limited to: Batch Records, SOPs, Work Instructions, Validation protocols.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

#Li-DD1

#Li-Onsite

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional 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 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.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

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

Legend Biotech maintains a drug-free workplace.