Director, QA Operations

BioSpace; Raritan (NJ); On-site; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech in Bridgewater, New Jersey, is seeking a Director, QA Operations to lead the Quality Operations team for CAR‑T cell therapy manufacturing. This role ensures cGMP compliance across disposition, batch records, and QC lab oversight, while developing long‑term quality programs and driving continuous improvement.

The candidate will manage senior managers, collaborate across sites, and align Quality Policies with business needs.

Qualifications

• Bachelor’s degree in Science, Information Science or equivalent technical discipline.
• Minimum 14 years of relevant work experience in aseptic manufacturing or quality-related roles.
• Knowledge of cGMP regulations and FDA/EU guidance for cell therapy products.
• Strong interpersonal and written/oral communication skills.
• Experience with quality systems and leading teams.

Responsibilities

• Manage daily quality activities for the QA operations team to ensure compliance with cGMP.
• Partner with Legend functional leaders to harmonize Quality Policies and Systems.
• Oversee incoming/final product disposition and batch record review at the site.
• Provide quality oversight of the QC laboratory and drive continuous improvement initiatives with the team.

Skills

Quality management

cGMP knowledge

Written and verbal communication

Leadership experience

Problem solving

Education

Bachelor’s Degree in Science or equivalent

Tools

Microsoft Office

Job description

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 Director, QA Operations as part of the Quality team based in Raritan, NJ.

Role Overview

The Director of Quality Operations, CAR‑T is responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. The role develops and implements long‑term and execution of Quality programs. This role will also be responsible for trending of quality operations metrics and developing continuous improvement initiatives for the team and processes. The Director also manages a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities.

Key Responsibilities

• Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements.
• Partners with other Legend functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
• Responsible for all aspects of incoming and final product disposition for the site.
• Responsible for batch record review activities for the site.
• Oversees quality shop floor program to ensure compliance of the manufacturing operations.
• Responsible for providing quality oversight of the QC laboratory.
• Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
• Manages team of senior managers and professionals within Quality. Hires and develops employees within the department.
• Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
• Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 14 years relevant work experience is required. It is preferable that the candidate has 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 manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Experience working with quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying process excellence tools and methodologies.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience developing and setting long-term objectives.
• Ability to identify/remediate gaps in processes or systems
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Proven People Management And Leadership Experience Is Required.
• Good Written And Verbal Communication Skills Are Required.

Pay Range (Base Pay)

$193,629 - $254,137 USD

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&DD 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.

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.