Associate Director, Compliance Risk, Audit and Monitoring

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking an Associate Director, Compliance Risk, Audit and Monitoring as part of the Compliance team based in Somerset, Nj.

Role Overview

This role oversees corporate compliance risk assessment, audit and monitoring activities. The successful candidate will develop an internal compliance risk assessment; lead, manage and coordinate compliance audit and monitor activities; facilitate oversight efforts across various business units; drive company policy alignment; and prepare reports, analytics and presentations. This proactive compliance role requires a solid understanding of the elements of an effective compliance program. The position is core driver in identifying, assessing, and mitigating compliance risks to protect the organization from potential regulatory and reputational harm. Reporting into the Senior Director Global Compliance Operations, the position will interact with various individuals ranging in seniority across various business units.

Key Responsibilities

• Develop, Implement and Conduct Compliance Risk Assessments: Identify and evaluate inherent and residual compliance risks across business units and functions. Coordinate a cohesive approach to align with an Enterprise-Wide Risk Assessment.
• Develop, Maintain, and Coordinate a Comprehensive Audit and Monitoring Plan: Design and execute risk-based compliance audit and monitoring activities to test control effectiveness across various business units.
• Collaborate with Stakeholders: Work closely with Internal Audit and other business units to address compliance gaps.
• Identify, Project Manage, and Track Compliance Remediation Efforts: In collaboration with applicable stakeholders and the compliance team, identify and implement corrective action necessary to address risk identified via the compliance risk assessment, audit and monitoring activities. Project manage timely closure of prioritized compliance improvements.
• Assist with Compliance Investigations: Assist the Senior Director Global Compliance Operations with investigations and the independent whistleblowing intake system. Gather, analyze and interpret relevant data to determine root cause issues.
• Drive efficiencies: The successful candidate will play a key role in reviewing and assessing all company policies to ensure alignment across global, regional, and local frameworks. This position requires the ability to analyze existing structures, identify gaps, and support the development of a cohesive governance model that promotes consistency. Reports and metrics for internal and external compliance reporting will be necessary to drive communications and updates across the business.
• Required to proactively drive compliance improvement with minimal supervision. The position requires the successful candidate to work closely with all members within the global compliance team. A mixture of independent and team decisions is necessary to determine applicable action, based on alignment within the team and the organization’s priorities. 

Requirements

• Bachelor’s degree or other advanced accredited compliance certification in Compliance Law or related field.
• 10 years in compliance with no less than 5 years in the pharmaceutical compliance or legal.
• Demonstrated experience and expertise in the seven elements of an effective compliance program, regulatory guidelines and industry codes.
• Proven ability in risk assessment, audit and monitoring of a comp