Quality Systems Lead

BioSpace; Raritan (NJ); On-site; USD 107,482 - 141,070; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Paid time off including 15 vacation days

Flexible spending and health savings accounts

Short- and long-term disability coverage

Life and AD&D insurance

Job summary

A global biotechnology company in Raritan, NJ, is seeking a Quality Systems Lead to oversee compliance and quality processes within a cell therapy manufacturing facility. The ideal candidate has a Bachelor's degree in a relevant field, at least 4 years of experience, and a strong understanding of quality assurance in an aseptic manufacturing environment. Responsibilities include managing CAPA programs and driving improvements in quality systems. The position offers a competitive salary and benefits package.

Qualifications

• Minimum of 4 years of relevant work experience in quality assurance, manufacturing compliance, or clinical quality.
• Knowledge of GxP quality systems and relevant regulations.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Provide oversight to the CAPA program for the CAR‑T manufacturing site.
• Oversee metrics, trending, and reporting of quality systems records.
• Drive continuous improvement of quality systems processes.

Skills

Analytical problem-solving

Communication skills

Attention to detail

Multitasking

Education

Bachelor’s Degree in Science or Engineering

Tools

Microsoft Office (Outlook, Excel, Word, PowerPoint)

Job description

Quality Systems Lead – Legend Biotech

Location: Raritan, New Jersey

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Quality Assurance

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.

Role Overview: The Quality Systems Lead is an exempt level position that supports quality systems processes within a cell therapy manufacturing facility to meet both clinical and commercial requirements in a sterile GMP environment. The role serves as the business process owner for the Corrective and Preventive Actions (CAPA) process and ensures compliance within quality systems processes.

Key Responsibilities:

• Provide oversight to the CAPA program for the CAR‑T manufacturing site.
• Oversee metrics, trending, and reporting of relevant quality systems records.
• Support CAPA site governance program.
• Drive continuous improvement of quality systems processes.
• Ensure compliance with current Good Manufacturing Practices (cGMP).
• Manage multiple and complex cross‑functional projects with many stakeholders.
• Support other quality systems activities as needed.
• Support drafting, review and approval of standard operating procedures and other required documentation.
• Collaborate with functional departments to resolve issues.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Require minimal direction to complete tasks, obtaining resources and information from established internal contacts, and consulting with supervisor for decisions outside established processes.

Requirements:

• A minimum of a Bachelor’s Degree in Science, Engineering, or equivalent technical discipline or relevant experience is required.
• At least 4 years of relevant work experience; experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy is preferred.
• Knowledge of GxP quality systems, including relevant regulations and guidances (e.g., 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
• Strong written and verbal communication, analytical problem‑solving and conflict resolution skills.
• Highly motivated, organized, and able to multitask with attention to detail.
• Ability to manage shifting priorities to meet critical deadlines in a fast‑paced, dynamic, growing environment.
• Flexibility in work schedule.
• Effective interpersonal skills with ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Ability to process complex information quickly.
• Proficiency in applying process‑excellence tools and methodologies.
• Experience leading ongoing projects and setting long‑term objectives.
• Ability to identify and remediate gaps in processes.
• Operational experience with electronic quality systems.
• Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).

Anticipated Base Pay Range: $107,482 – $141,070 USD.

Benefits: We offer a best‑in‑class benefits package that includes medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer recognition programs.

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. We 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.