BioSpace
Associate Director, Compliance Risk, Audit and Monitoring
BioSpace, Trenton, New Jersey, United States
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.
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 a 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: play a key role in reviewing and assessing all company policies to ensure alignment across global, regional, and local frameworks. 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.
Proactively drive compliance improvement with minimal supervision. 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 compliance program.
Proven ability to analyze complex and unique issues, exercising sound judgment and applying advanced methodologies to drive improvements.
Critical thinking and fostering collaboration across diverse functional areas and geographies.
History of guiding cross‑functional teams and delivering results within matrixed organizational structures.
Highly adept at prioritizing initiatives and managing multiple confidential projects in dynamic, fast‑paced environments.
Exceptional interpersonal and communication skills, ensuring alignment and influencing stakeholders effectively.
High proficiency in project management to enhance efficiency and the implementation of compliance remedial activities.
Advanced organizational, analytical, and presentation skills, consistently driving results and operational excellence.
IT Skills: Microsoft PowerPoint, Excel, Whistleblower Intake System.
The anticipated base pay range is $142,146 - $186,567 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)‑retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&DD insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs – demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
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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.
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 a 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: play a key role in reviewing and assessing all company policies to ensure alignment across global, regional, and local frameworks. 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.
Proactively drive compliance improvement with minimal supervision. 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 compliance program.
Proven ability to analyze complex and unique issues, exercising sound judgment and applying advanced methodologies to drive improvements.
Critical thinking and fostering collaboration across diverse functional areas and geographies.
History of guiding cross‑functional teams and delivering results within matrixed organizational structures.
Highly adept at prioritizing initiatives and managing multiple confidential projects in dynamic, fast‑paced environments.
Exceptional interpersonal and communication skills, ensuring alignment and influencing stakeholders effectively.
High proficiency in project management to enhance efficiency and the implementation of compliance remedial activities.
Advanced organizational, analytical, and presentation skills, consistently driving results and operational excellence.
IT Skills: Microsoft PowerPoint, Excel, Whistleblower Intake System.
The anticipated base pay range is $142,146 - $186,567 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)‑retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&DD insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs – demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech.
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
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