Legend Biotech · 2 months ago
Director of External Manufacturing Quality
Somerset, New Jersey, United States
Full-time
Onsite
Director/Executive
$188K/yr - $247K/yr
14+ years expLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. The Director of External Manufacturing Quality will oversee external manufacturers to ensure compliance with cGMP clinical requirements and manage a team within the QA department.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Serves as the External Manufacturing Quality Lead in support of cell therapy pipeline manufacturing operations at Contract Manufacturing Organization (CMOs)
Provide leadership and oversee the Quality functions (Quality Assurance, Quality Systems, Quality Control) of external CMOs
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 Product lifecycle management at the CMO
Provide guidance and direction for policies and quality management system for clinical phase manufacturing
Partners with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked
Establish a Quality Management Review program to review and analyze external quality metrics
Perform audits of CMOs as needed
Develop and negotiate Quality agreement with the CMOs
Liaison between Legend and the CMOs during any Health authority inspections of the CMO facilities
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Travel as needed to CMOs to support quality activities, up to 50%
Other duties will be assigned, as necessary
Works in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing 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
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
Experience working with quality systems 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
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
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred
Experience with 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
legacy.thefly.com
2026-01-22
2026-01-22
Company data provided by crunchbase