Sr. Director, Global Quality Compliance at Legend Biotech

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline

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
Manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities

Skills

Quality Compliance

Regulatory Guidelines

Quality Auditing

Inspection Readiness

QA Management

GMP

Quality Assurance

Compliance Programs

Metrics Implementation

Team Leadership

Legend Biotech

Develops and commercializes cell therapies

About Legend Biotech

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Franklin Township, New JerseyHeadquarters

2014Year Founded

$146.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

Risks

Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.

Collaboration with Multiply Labs may face technological challenges, delaying production timelines.

Financial strain from new R&D facility could affect operational focus if advancements lag.

Differentiation

Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.

The company is technology agnostic, exploring multiple platforms for effective cancer treatments.

Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

Upsides

Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.

New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.

Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

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