Sr. Specialist, Quality IT

BioSpace; Bridgewater Township (NJ); In loco; USD 111.000 - 145.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision insurance

401(k) match

Paid time off & holidays

Parental leave

Descrizione del lavoro

Legend Biotech in Bridgewater, NJ is seeking a Sr. Specialist, IT Quality to provide oversight and hands-on support for GxP computerized systems, ensuring compliance with FDA/21 CFR Part 11, EU Annex 11, and GAMP 5.

You will review validation documents, manage risk, collaborate with IT, QA, and suppliers, support audits, and drive continuous improvement across the CSV/CSA lifecycle.

Competenze

• 7+ years in pharmaceutical/biotech or medical-device industry with at least 4 years in QA or regulated lifecycle activities.
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Experience reviewing/authoring validation and lifecycle deliverables such as risk assessments, requirements, test protocols, traceability matrices, validation reports, change controls, deviations, and CAPAs.
• Experience with enterprise platforms such as QMS, LIMS, Veeva, SAP, ERP.
• Experience supporting audits or regulatory inspections is preferred.
• Experience with clinical systems is preferred.

Mansioni

• Ensure GxP IT systems and records comply with CSV/CSA and regulatory requirements.
• Provide IT Quality oversight for system implementations, enhancements, upgrades, validation activities, and change controls.
• Review validation and lifecycle documents, including plans, risk assessments, URs, test protocols/reports, traceability matrices, release docs, and retirement records.
• Collaborate with IT, business, validation, quality, and system owners for maintenance and upgrades.
• Support SOPs, work instructions, templates, and standards for GxP computerized systems.
• Assess risks and implement risk controls for GxP systems.
• Assist investigations of issues, deviations, data integrity concerns, and CAPAs.
• Track audit observations, deviations, CAPAs, and remediation actions.
• Support supplier qualification and annual supplier audits.
• Provide oversight for periodic reviews, access reviews, backups, security and audit trails.
• Assist inspections by retrieving records and coordinating responses.
• Monitor regulatory developments and translate into procedural improvements.
• Provide training on GxP, CSV/CSA, data integrity, electronic records and signatures.
• Drive continuous improvement through metrics and trend analysis.
• Manage multiple assignments with limited supervision.

Conoscenze

GxP knowledge

Regulatory compliance

Technical writing

Analytical skills

Problem solving

Communication

Prioritization

Formazione

Bachelor’s degree in Science, Information Technology, Engineering, or equivalent

Advanced degree or professional certification preferred

Strumenti

QMS

LIMS

Veeva

SAP

ERP

Document management system

Descrizione del lavoro

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 a Sr. Specialist, Quality IT as part of the Quality IT team based in Bridgewater, NJ.

Role Overview

The Sr Specialist, IT Quality provides IT Quality oversight and hands-on support for the implementation, validation, operation, and lifecycle management of GxP computerized systems within Legend Biotech. The role interprets applicable regulatory requirements, applies IT Quality Assurance standards, and supports compliant processes and documentation. The position helps ensure that GxP electronic systems and records comply with company procedures and applicable requirements for electronic records, electronic signatures, data integrity, cGMP, GCP, GLP, FDA 21 CFR Parts 210, 211 and 11, EU Annex 11, and GAMP 5 guidance.

Key Responsibilities

• Ensure assigned GxP IT systems, processes, and records comply with Legend CSV/CSA and SDLC procedures and applicable regulatory requirements.
• Provide IT Quality review and oversight for GxP system implementations, enhancements, upgrades, validation activities, and associated change controls.
• Review validation and lifecycle documents, including validation plans, system risk assessments, user requirements, test protocols and reports, traceability matrices, release documentation, and retirement records.
• Partner with IT, business, Validation, Quality, and system owners to support system maintenance, upgrades, issue resolution, and compliant operation.
• Support the development, revision, and implementation of SOPs, work instructions, templates, and standards governing GxP computerized systems.
• Assess and document risks associated with GxP computerized systems and processes and support implementation of appropriate risk controls.
• Support investigations of system or application issues, deviations, data-integrity concerns, and recurring error trends; contribute to root-cause analysis and corrective and preventive actions.
• Track assigned audit observations, deviations, CAPAs, and remediation actions to timely completion in accordance with internal procedures.
• Support the IT supplier qualification and annual supplier audit program, including assessment documentation, audit preparation, follow-up, and record maintenance.
• Provide Quality oversight for system periodic reviews, access reviews, backup and recovery evidence, security and audit-trail reviews, and other lifecycle controls, as applicable.
• Support inspection readiness and participate in internal audits, supplier audits, and regulatory inspections by retrieving records, explaining controls, and coordinating responses.
• Monitor relevant regulatory and industry developments and help translate new expectations into practical improvements to procedures and controls.
• Provide guidance and training to IT personnel and key stakeholders on GxP, data integrity, CSV/CSA, electronic records and signatures, and internal Quality requirements.
• Support continuous improvement through process metrics, trend analysis, lessons learned, and risk-based simplification of validation and Quality processes.
• Manage multiple assignments with limited day-to-day direction, elevate significant compliance risks promptly, and seek management guidance for complex or precedent-setting decisions.
• IT leadership and delivery teams; Quality Assurance and Validation; system and business process owners; project management; Information Security; Data Integrity; internal audit and inspection-readiness teams; and external software, service, and consulting suppliers.

Requirements

• Bachelor’s degree in Science, Information Technology, Engineering, or an equivalent technical discipline.
• An advanced degree or relevant professional certification is preferred.
• A minimum of 7 years of relevant experience in the pharmaceutical, biotechnology, or medical-device industry, including at least 4 years supporting Quality Assurance, computerized system validation/assurance, IT Quality, or regulated computerized-system lifecycle activities.
• Working knowledge of global GxP requirements and expectations for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Experience reviewing or authoring validation and lifecycle deliverables such as risk assessments, requirements, test protocols, traceability matrices, validation reports, change controls, deviations, and CAPAs.
• Experience with one or more enterprise or regulated platforms, such as QMS, document management, validation management, change control, LIMS, Veeva, ERP, or SAP.
• Ability to apply risk-based CSV/CSA principles and translate compliance requirements into practical actions.
• Strong technical writing, documentation-review, analytical, and problem-solving skills.
• Ability to communicate clearly and collaborate effectively with internal stakeholders and external suppliers.
• Ability to prioritize and manage multiple concurrent assignments while maintaining documentation quality and meeting commitments.
• Highly motivated, adaptable, organized, detail-oriented, and capable of working with limited day-to-day supervision.
• Experience Supporting Audits Or Regulatory Inspections Is Preferred.
• Experience with clinical systems is preferred.

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)

$110,706 - $145,303 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.