Sr. QA Validation Specialist, CSV & Equipment

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.

Legend Biotech is seeking a Sr. QA Validation Specialist, CSV & Equipment as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. QA Validation Specialist, CSV & Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity.

Key Responsibilities

• Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site
• Review and approve qualification/validation documentation (specifications, protocols, reports).
• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration).
• Provide expertise and solutions to issues regarding qualification and validation strategies and documentation.
• Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems.
• Assist in the development of validation and qualification related policies, procedures, templates, forms.
• Provides quality oversight on data integrity of systems, instruments, and equipment used at the site.
• Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.
• Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site.
• Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Drive continuous improvement.
• Provide training and guidance to other members of the team.
• Other duties may be assigned, as necessary. 

Requirements

• A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required.
• 7+ 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 biopharmaceuticals. Experience in supporting cell-based products is a plus.
• Strong knowledge of GxP compliance.
• Experience in cGMP regulatory body audits.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information.
• Ability to work independently and be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow procedures closely.
• Ability to identify and assess possible gaps and work collaboratively to address such issues.
• Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Experience reviewing/auditing GMP documentation.
• Strong proficiency with using Microsoft Office applications. 

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

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

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.

Pay Range (Base Pay):

$123,605—$162,232 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.