Legend Biotech · 5 hours ago
Senior Director of Quality Operations
Raritan, NJ
Full-time
Onsite
Director/Executive
$216K/yr - $284K/yr
16+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Senior Director of Quality Operations will lead CAR-T manufacturing facilities in the United States, ensuring compliance with cGMP requirements while managing a team and collaborating with external partners.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Hiring Manager
Breanna (Vazquez) Zalewski
Responsibilities
Serves as the Quality Lead in support of cell therapy manufacturing and operations within the United States
Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel
Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and cell therapy products
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations
Partners with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
Proactively develops and sustains strong relationships with local/regional/national regulatory authorities
Analyzes regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued
Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility
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
Qualification
Required
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required
A minimum of 16 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
Proven people management and leadership experience is required
Extensive knowledge of chemical, biochemical and microbiological concepts is required
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
Good written and verbal communication skills are required
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
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
Preferred
Experience working with quality systems is required
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company 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
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase