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Associate Director, Quality IT

Somerset, New Jersey, United States

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 an Associate Director, Quality IT as part of the Compliance team based in Somerset, NJ.

Role Overview

The Associate Director, Quality IT is responsible for leading the IT Quality team and providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems(eSystems) adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.

Key Responsibilities

  • Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements.
  • Provide IT Quality oversight for GxP eSystem enhancement and validation activities inclusive of documentation and change controls.
  • Direct and manage the IT Quality Team activities in accordance with compliance and business priorities.
  • Contribute to the development and enforcement of applicable standard operating procedures at Legend.
  • Work with cross functional teams for eSystem upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance.
  • Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and reports; System Risk Assessments, Standard Operating Procedures; and Requirements Traceability Matrices.
  • Maintain master files, profiles and tables for multiple software applications and drive harmonization across systems.
  • Review and approve IT systems change management documentation, authorizing system use upon verification that requirements are met.
  • Monitor error reports and assure data integrity. Investigate and document application problems and recommend system and/or procedural changes.
  • Develop, maintain and execute the annual IT supplier audit program.
  • Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated, in compliance with internal policies and procedures as well as with all applicable regulatory requirements.
  • Provide Quality oversight for SOPs governing use and validation of eSystems.
  • Work cooperatively with members of interdepartmental eSystem committees to ensure seamless communication among eSystems.
  • Identify and mitigate risks associated with GxP IT systems and processes, developing strategies to address compliance risks.
  • Train IT personnel and key stakeholders on GxP requirements and standards for computerized systems.
  • Ensure that staff are developed and knowledgeable of regulatory expectations.
  • Support continuous improvement efforts through the monitoring of process performance and metrics.
  • Assist with inspection readiness efforts and program implementation.
  • Support GxP regulatory inspections as required.
  • Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments.
  • Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR).
  • Establish key stakeholder relationships with all Legend Leadership Team, Legend Functional Leads, Legend Project Management, Legend Quality and Legend IT.

Requirements

  • A minimum of a Bachelor’s degree in Science, IT, Engineering or equivalent technical discipline. Advanced degree preferred.
  • 12 years of relevant work experience within a pharmaceutical / biotech industry is required. A minimum 8 years of IT quality leadership experience is also required.
  • Experience collaborating and communicating effectively with internal and external stakeholders.
  • Proficiency in QMS software, document control, validation tools, change control systems, LIMS, ERP systems (SAP considered a plus).
  • Ability to clearly represent compliance requirements and drive continuous improvement following risk-based approaches.
  • Highly motivated, flexible, and excellent organizational skills.
  • Experience working in Quality Assurance, Quality Systems and/or IT.
  • Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus).
  • Excellent verbal and written communication skills.
  • Ability to prioritize and balance work from multiple projects in parallel.
  • Regulatory Agencies firsthand inspection experience considered a plus.
  • Clinical and GLP audit experience considered a plus.

#Li-BZ1

#Li-Hybrid

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):

$163,468 - $214,551 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 policy, please review: Legend Biotech Privacy Policy.

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I (the candidate) enter into this Non-Disclosure Agreement (the “Agreement”) with Legend Biotech USA Inc. (the “Company”), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me.

  1. Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below.  I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a) not use or disclose any Confidential Information; (b) keep all Confidential Information confidential at all times; and (c) not copy, reproduce or modify any Confidential Information.
  2. Definition of “Confidential Information.” For purposes of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know-how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure.
  3. Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer.  I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public.
  4. Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies.
  5. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California.  This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

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