Legend Biotech · 10 hours ago
QA Investigations Supervisor
Raritan, NJ
Full-time
Onsite
Mid, Senior Level
$93K/yr - $123K/yr
5+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The QA Investigations Supervisor will guide a team of QA Investigation Leads, ensuring compliance with regulatory requirements and supporting continuous improvement projects within the Raritan Investigations organization.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Supervise QA Investigation Leads: • Lead daily touch point meetings with their direct reports and monitor QA Investigation Lead workload
Provide guidance to quality leads in investigation performance, process knowledge of cell and gene therapy manufacturing, and compliance to ensure that investigations reviewed by the team adhere to a high standard of excellence
Investigation Support: • Responsible for ensuring that the investigation processes are compliant with all applicable regulatory requirements
Escalation of events that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release to management
Supporting the review of investigation execution related documents (SOP’s, Work Instructions, Job Aides)
Support QLs in the resolution of Roadblocks for investigations to ensure compliant closures in support of batch release and site timeliness goals
Investigation Metrics Ownership: • Ensure the health of the investigation process by owning and monitoring investigation metrics and implementing actions when metrics indicate a negative trend or failure to meet accepted criteria
Internal/External Audit Readiness/Support: • Serve as the Subject Matter Expert in preparation for and during both internal and external audits, including FDA, EMEA, etc
Ensuring a high level of competency and audit/inspection readiness of the overall Raritan investigation team
Coaching quality leads to audit readiness and preparing them and quality records for audits/inspections
Continuous Improvement Project Support: • Representing quality on the project improvement team, ensure process improvements are implemented incorporating quality risk management principles and that current effective reference documents supporting investigations are updated appropriately
Qualification
Required
A minimum of a bachelor's degree in science or related field or equivalent experience required
A minimum of 5 years of Quality Assurance experience within a cGMP environment in the biotech/biopharma industry
A minimum of 2 years of experience managing a team
Significant experience utilizing training and quality tracking systems
Demonstrated experience in handling/leading complex multi-disciplinary investigations in a cGMP environment
Experience partnering with various levels of leadership across complex organizations
Ability to build strong partnerships and effectively integrate with Internal and external partners to drive projects/programs forward in a matrixed environment
Excellent organizational and project management skills with the ability to simplify and clearly communicate complex concepts
Strong analytical, problem solving, and decision-making skills
Excellent verbal, written, and presentation capabilities
Energetic and collaborative
Proficient in data collection and analysis
Ability to critically review investigations to guide quality leads through the process of identifying and implementing improvements consistent with quality risk management principles
Must be capable of coaching and instructing others in analytical thinking
Must have the ability to develop and instruct both individuals and groups of individuals in a skill development environment
Preferred
Advanced degree preferred
Cell/Gene Therapy cGMP manufacturing experience preferred
Benefits
Medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
Eight (8) weeks of paid parental leave after just three (3) months of employment
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company 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