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Associate Director, Quality Systems

Raritan, New Jersey, United States

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an Associate Director, Quality Systems as part of the Quality team based in Raritan, NJ. 

Role Overview

The Associate Director, Quality Systems is a member of the Raritan Quality Leadership Team with responsibilities for quality systems oversight within a cell therapy manufacturing plant to support commercial requirements in a sterile GMP environment. This role will oversee a team of quality systems specialists responsible for managing systems and associated processes and procedures, including document control, investigations, CAPA, change control, site quality metrics, and laboratory QA oversight. They will also support site quality compliance, including site inspection readiness and support during regulatory inspections.

Key Responsibilities

  • Provide quality systems oversight for the CAR-T manufacturing site
  • Responsible for oversight of Quality Systems, Systems Support, and Investigations teams to meet goals and deadlines.
  • Ability to manage multiple and complex projects, provide status reports, and coordinate with other departments
  • Manage cross-functional projects with many stakeholders and collaborate with functional departments to resolve issues.
  • Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
  • Identify efficiencies within the teams to enhance compliance and improve productivity.
  • Lead the implementation and continuous improvement of Quality Risk Management (QRM) processes in accordance with applicable regulatory requirements and site procedures
  • Facilitate cross-functional risk assessments (e.g., FMEA, hazard analysis, impact assessments) to identify, evaluate, and mitigate quality, compliance, and operational risks.
  • Ensure risks associated with investigations, deviations, CAPAs, changes, and process improvements are appropriately assessed, documented, and monitored through closure.
  • Monitor quality trends, recurring events, backlog metrics, and emerging signals to proactively identify systemic risks and recommend preventive actions.
  • Partner with Manufacturing, Quality Control, Engineering, Supply Chain, and Technical Operations to harmonize procedures, processes and systems, and drive risk-based decision making across site operations.
  • Present key quality and compliance risks, mitigation strategies, and risk trends to site leadership and governance forums.
  • Evaluate the effectiveness of risk controls and CAPAs to ensure sustainable risk reduction and prevention of recurrence.
  • Drive a proactive risk culture by coaching investigators, quality leads, and cross-functional teams on risk identification, assessment methodologies, and mitigation strategies.
  • Utilize quality metrics and analytics to identify high-risk processes, recurring failure modes, and opportunities for continuous improvement.
  • Lead and provide expert guidance for complex, high-risk, critical, and OOS investigations; facilitate investigation strategy meetings and root cause analysis workshops.
  • Review and approve highly complex investigations, CAPAs, corrections, and effectiveness checks to support robust root cause determination and sustainable corrective actions.
  • Monitor, trend, and report investigation and CAPA quality, timeliness, backlog, aging, recurrence, and effectiveness metrics; develop dashboards, KPIs, and performance management tools
  • Lead investigation excellence initiatives focused on investigation quality, cycle time, root cause effectiveness, inspection readiness, and site-wide accountability.
  • Lead governance forums, including Quality Lead meetings, CAPA Forum, and investigation coaching and mentoring sessions.
  • Provide guidance to other employees in the interpretation of quality issues
  • Develop project charters, timelines, resource plans, risk assessments, and success metrics; lead cross-functional teams through implementation and sustainment.
  • Support improvements to procedures, standards, training qualification, coaching, and governance processes; lead maturity assessments and benchmarking activities.
  • Manage strategic and continuous improvement projects supporting process optimization, CAPA effectiveness, digitalization, compliance enhancement, and quality risk management integration.
  • Act as the Investigation Governance SME during audits and regulatory inspections; present program metrics and governance activities and drive sustainable responses to observations.
  • Support regulatory inspections and audits by serving as a subject matter expert for Quality Systems.
  • Support Global Quality and Site Compliance Team by conducting periodic reviews of site compliance, inspection readiness, and quality system health to identify and mitigate emerging compliance risks
  • Perform responsibilities in accordance with safety policies, quality systems, and cGMP requirements; complete other duties as assigned.
  • Works collaboratively with Quality Control, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning, Quality Assurance, Validation, Quality Compliance, above-site stakeholders, business units, and other functional investigation leaders.

Requirements

  • Bachelor’s degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology, or a related technical discipline is required. An advanced degree is preferred.
  • Minimum 10 years of Quality experience within a cGMP-regulated manufacturing facility, biotechnology, biopharmaceutical, or Cell & Gene Therapy manufacturing environment. Sterile manufacturing experience preferred. Demonstrated experience leading quality systems, complex investigations, CAPA programs, governance programs, quality improvement initiatives, cross-functional projects, and regulatory inspection or audit readiness activities is required.

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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):

$146,410 - $192,164 USD

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

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

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.

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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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