Legend Biotech · 2 days ago
Sr. Director, Global Quality Compliance
Raritan, NJ
Full-time
Onsite
Director/Executive
$216K/yr - $284K/yr
14+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Head of Compliance will provide quality oversight for the compliance program within the global quality organization, ensuring alignment with regulatory guidelines and managing a team to support compliance initiatives.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Hiring Manager
Breanna (Vazquez) Zalewski
Responsibilities
Manage the global Compliance leads to ensure harmonization and alignment across all functions and sites
Support the development of the GMP Compliance program related to clinical/ commercial stage and manufacturing
Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments
Assist with inspection readiness efforts and program implementation across all sites
Manage and support the implementation of the internal and external audit program
Schedule, execute, report and follow-up on internal and US and Global external audits (travel required)
Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as with all applicable regulatory requirements
Support GxP regulatory inspections as required
Support the local Compliance and auditing teams for continuous improvement projects
Support the enhancement and Global harmonization of the supplier qualification program, including management of the electronic systems for this program
Work with External Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard
Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR)
Support management of the Quality Management Review (QMR) program
Support continuous improvement efforts through the monitoring of audit metrics
Assist with the development, maintenance and execution of the annual audit programs
Works in a collaborative team setting with quality counterparts that include Quality Leads, site Compliance Leads, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning
Qualification
Required
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
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
Extensive experience participating in regulatory inspections and internal audits
Strong interpersonal and written/oral communication skills
Proven people management and leadership experience is required
Experience working with quality systems is required
Extensive knowledge of chemical, biochemical and microbiological concepts is required
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
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Preferred
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
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred
Experience with collaborating and communicating effectively with service providers, suppliers, and CMO/CDMOs
Experience with ICH and/or 21 CFR parts 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 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
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