Legend Biotech is seeking a Manager of Internal Audit as part of the Internal Audit team based in Bridgewater, NJ. 

Role Overview

Legend Biotech (the Company) seeks a high performing manager to join the Internal Audit (IA) department. This individual will be responsible for leading a broad range of Sarbanes-Oxley Act (SOX) control testing and internal audits including, but not limit to, Financial, Operational, Compliance, Technology audits and special projects independently and proficiently, following the COSO Framework and Institute of Internal Auditor (IIA) Standards.

The key objective of this role is to provide an independent and objective assessment of, as well as add value to improve the Company's control and operation environment to ensure compliance, effectiveness and efficiency. The Manager of Internal Audit will apply IA’s Policy and Procedure to skillfully manage audit lifecycle from planning, to scoping, fieldwork, reporting and following through audit remediations. This role will report to the Global Head of Internal Audit and collaborate with other IA team members, business process owners, key stakeholders, and external auditors.

The key characters expected to the Internal Audit Manager include being risk conscious, control driven, critical thinking, proactive, relationship building, strong written and verbal communication skills, multi-tasking, time management, team player, and act with sense of urgency and ownership.

Key Responsibilities  

• Manage internal audit risk assessment, develop audit universe, identify auditable projects, and conduct risk-based audit project planning and scoping.
• Follow Internal Audit Methodology and Procedure to manage audit lifecycle from audit planning to audit reporting to meet audit objectives and to ensure compliant, effective and efficient processes and controls are in place:
  • Gather critical audit related information via asking probing questions in interviews with key process owners, to assess business processes and the maturity of their control environments.
  • Conduct data analysis in risk assessment and execution of audits.
  • Be able to independently develop and clearly articulate a risk-based audit program to clearly include risks, objective, control, and test steps.
  • Hands on manage testing process that address high risk areas in scope in accordance with Legend Internal Audit and IIA Standards.
  • Identify control gaps, improvement opportunities, and value-added recommendations to strengthen and improve the control environment.
  • Review project team member’s workpaper for completeness, accuracy, adequacy and compliance.
  • Evaluate the risk and potential business impact of identified deficiencies.
  • Document audit workpapers with reperformance standards to include test attributes, associated risks, test conclusions, and opportunities for process improvement.
• Independently conduct and document the walkthroughs and tests of controls, to evaluate the effectiveness of the Company’s SOX 404 program.
• Track identified audit deficiencies/observations and ensure the completion of audit remediations.
• Collaborate with and educate process owners on the importance of maintaining strong controls.
• Build strong relationship with business functions and act as a trusted business partner to provide expert insights in the areas of operational audits and SOX audits where the incumbent will review, evaluate and recommend actions to improve control and risk management.
• Proactively engage in various departmental activities to help build Internal Audit brand name, promote integrity-culture within company, and develop junior staff through positive and energetic mindset.
• Act with sense of urgency and strong accountability to work in a fact growing company; being a role model to demonstrate professional due care; being sensitive to various operational risks and strong sense of control; being able to articulate thought process and communicate concisely verbally and in written (email, workpaper, audit report); being able to hands on and work with junior staff to help them grow professionally; being able to keep Audit Leader closely updated on different risks, project status, challenges, and/or new ideas etc.
• Passionate about Internal Audit profession, and be able to actively participate all kinds of internal audit training program to advocate internal audit mission statement and value proposition, and goal of partnering with business stakeholders in building a more effective process and culture of integrity together.

Requirements

• Bachelor’s degree from an accredited college / university required
• Masters, MBA, or CPA, CIA, CISA, CISM strongly preferred, especially CFE
• Minimum 6 years of experience in auditing (combination of internal and/or external).
• Experience with Sarbanes-Oxley (SOX) is required.
• Experience with operational audits is required.
• Fraud examination experience is strongly preferred.
• Experience in Public Accounting is preferred.
• Critical thinking and data analytical skills are required to be able articulate high risks using data insights.
• AI featured auditing skills is preferred.
• Experience in the industries of pharmaceutical, life science, biotech is strongly preferred.
• Experience in manufacturing is strongly preferred.
• Experience in any of the following: risk assessment, data analytics tools is preferred. Excel/Word/PowerPoint capability required.
• Strong sense of ownership on any audit assignment to be able to proactively propose solutions and follow the task through completion.
• Strong sense of urgency to execute assignment with adaptation, agility and prioritization.
• Strong risk-conscious critical thinking skills to be able to execute each step of the audit cycle (planning, scoping, risk-control matrix designing, fieldwork testing, reporting and remediation).
• Ability to work independently, objectively and collaboratively, as required, in a fast-paced and matrixed team environment consisting of internal and external team members, and other assurance business stakeholders.
• Ability to manage multiple projects simultaneously, to meet deadline requirement without compromising quality of deliverables.
• Strong sense of self-awareness to be willing to learn new areas quickly, be growth minded and to accept challenges for continuous improvement.
• Ability to articulate issues and remediations clearly and concisely, supported by factual details, both written and verbal, to different level of management.
• Process-oriented and control-driven with strong analytical skills for analyzing controls, identifying risks and assessing their efficiency and effectiveness.
• Knowledge of U.S. GAAP & IFRS and IIA standards is required.

#Li-LB1

#Li-Hybrid

Please note that this position can be based in San Diego, CA OR Princeton, NJ OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Manager, Quality Audits is responsible for leading and executing internal and external audits across Acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations, maintaining robust Quality Agreements, and supporting the ongoing effectiveness and continuous improvement of Acadia’s Quality Management System. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations. 

Primary Responsibilities

• Plan, coordinate, schedule, and conduct internal and external GMP/GxP compliance audits, ensuring CSPs meet Acadia standards and all applicable FDA, EU (EudraLex), Canadian, and international regulatory requirements
• Prepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management review
• Develop, review, negotiate, and maintain quality agreements with clinical and commercial CSPs
• Maintain and continuously improve the internal audit program, including coordination of GxP audit activities with internal and external stakeholders
• Prepare, review, format, and maintain SOPs, and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
• Provide GMP compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall events
• Support the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including CSV support as needed
• Lead and support continuous improvement initiatives aligned with GMP and industry best practices, while ensuring compliance with company policies, including Privacy/HIPAA and other legal requirements
• Other duties as assigned

Education and Experience

• Bachelor’s degree in a Life Sciences or related field.  An equivalent combination of education and applicable job experience may be considered.
• Targeting 6 years of progressively responsible experience within quality assurance (QA), including 3 years directly responsible for GMP QA, with knowledge of external and internal auditing.
• Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
• American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus.

Key Skills:

• In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
• Demonstrated expertise in QA activities and GMP regulations (FDA, EU, ICH) across clinical development, manufacturing, technology transfer, and commercial operations
• Strong ability to interpret and apply U.S. and international cGMP requirements
• Proven experience conducting internal audits, supplier audits, and manufacturing site inspections
• Ability to translate quality standards into practical implementation and review activities
• Clear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
• Strong collaboration skills with the ability to influence and gain cooperation across functions
• Willingness to travel domestically and internationally (approximately 25–30%)

Scope

Manages department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems.  Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. It will require a focus on issues of moderate to diverse scope which will require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-Hybrid #LI-SL1

Who We Are

Cross River builds the infrastructure behind the world’s most innovative financial products. Our technology and capital solutions power payments, cards, lending, and digital asset capabilities that move money safely, instantly, and inclusively — trusted by leading fintechs, enterprises, and disruptors across the globe.

Our mission is simple: to build the financial infrastructure that expands access and opportunity for all. Guided by a culture of collaboration, curiosity, and purpose, Cross River has been named one of American Banker’s Best Places to Work in Fintech year after year. Whether you’re designing code, solving regulatory puzzles, or developing strategy, you’ll join a team where innovation and integrity drive everything we do — and where your work helps shape the future of finance.

What We're Looking For

We are looking for an Information Security Analyst to help ensure demonstrable adherence to applicable IT governance requirements across multiple ITSM and information security processes. You will work effectively and efficiently with cybersecurity, engineering, product, and IT operations teams at various levels of the organization. The ideal candidate is self-motivated, solutions-oriented, detail-focused, and an independent thinker. You possess a strong understanding of the software development lifecycle (SDLC), change management, and IT risk management. You can quickly grasp complex technical concepts and can make them easily understandable in discussions, presentations, and high-quality documentation.

Responsibilities:

• Act as a subject matter expert on information security and ITSM industry best practices, standards, frameworks, and regulatory guidance
• Collaborate with cross-functional teams to help maintain standards, procedures, and evidence documentation
• Facilitate the change management process and production deployment evidence reviews
• Monitor, report, and assess the effectiveness of performance and conformance controls
• Facilitate information security training and awareness campaigns
• Coordinate the collection of evidence to support IT audits and examinations
• Maintain control mappings and perform gap analyses to drive continuous program improvement
• Identify, propose, and implement process improvement for information security processes

Qualifications:

Must Have:

• Exceptional written and verbal communication skills, with the ability to present complex information in a clear and concise manner to diverse audiences
• 3+ years of relevant experience in roles such as cybersecurity analyst, IT auditor, software engineer, IT business analyst, IT systems analyst, IT product owner, technical product manager, or IT project manager
• Strong understanding of the software development lifecycle (SDLC), change management, and/or IT risk management

Preferred:

• Undergraduate or graduate degree in computer science, cybersecurity, information assurance, business administration, or a closely related field
• Professional certificates or certifications such as ITIL 4 Foundation, ISO/IEC 27001 Foundation, CompTIA Security+, ISC2 CC, ISC2 CGRC, or ISACA CRISC
• Familiarity with regulatory guidance, standards, and frameworks such as the FFIEC IT Handbook, SOC 1/2, PCI DSS, COBIT 2019, and ITIL
• Experience working in a highly regulated environment such as financial services, military, or healthcare

#LI-AC1 #LI-Hybrid

Salary Range: $70,000.00 - $90,000.00