Associate Director, GxP Compliance and Auditing

Key Responsibilities

• Lead and own global GxP compliance and auditing programs.
• Serve as the Global Business Process and System Owner for Compliance and Auditing.
• Define, implement, and maintain compliance processes, procedures, tools, and training for internal and external auditing, inspection readiness, Quality Management Review, emerging regulations, regulatory trends, and quality planning.
• Develop, implement, and continuously improve compliance processes and systems.
• Identify, implement, and maintain IT solutions that support compliance and auditing programs.
• Interpret and apply global regulations to ensure process and system compliance.
• Apply a risk-based approach to ensure areas of higher risk are visible across the organization.
• Identify and manage resource needs to support organizational growth and operational priorities.
• Drive quality metrics, risk-based methodologies, and continuous improvement initiatives.
• Establish audit trends, metrics, and quality system governance.
• Support and advise stakeholders on GxP compliance requirements.
• Partner with operational groups and network sites to foster a proactive compliance culture.
• Demonstrate alignment with Legend’s core values and behaviors.
• Ensure compliance across the organization by sustaining a level of constant inspection readiness to meet regulatory requirements, guidelines and industry standards.
• Drive the Inspection Readiness Program that proactively prepares the site for Health Authority/External Party inspections (training, pre-audit preparation, tools, hosting, close-out etc.).
• Maintain and deploy Inspection Risk Assessment Processes and Scorecards.
• Provide PAI/PLI and audit training.
• Host/support Internal Audits and host/co-host External Health Agency Inspections (Somerset and Raritan-CARVYKTI).
• Facilitate and participate in Health Authority/External Party Inspections.
• Develop and manage the response process for Health Authority and External Partner audit observations.
• Ownership of Compliance-Aligned Quality Documents (Som

Requirements

• Bachelor’s degree in a scientific or technical discipline required (e.g., Life Sciences, Engineering, Pharmacy, or related scientific/technical discipline).
• Advanced degree (MS, MBA, PhD) preferred.
• Minimum 12 years of relevant GxP work experience in Quality, Quality Compliance, Regulatory, or related functions within the biopharmaceutical or advanced therapies industry.
• Minimum 5 years of leadership experience, including senior-level project planning and execution.
• Demonstrated success leading through influence in a matrixed organization; experience managing direct reports is beneficial but not required for this role.
• Proven experience conducting internal audits, hosting external audits, and supporting global health authority inspections.
• Experience implementing global processes and driving cross-site alignment.
• Experience working across all GxP functions (GMP, GDP, GCP, GLP) preferred.
• 20% travel is required.
• Knowledge of GxP requirements for quality systems and processes that enable compliance.
• Deep expertise in global GxP regulations and quality compliance frameworks, including: 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP Regulations.
• Experience conducting internal audits and self-inspections, including writing audit reports, issuing observations, and ensuring follow-through to closure.
• Experience in Regulatory Intelligence mining.
• Experience hosting front-room/back-room activities for external audits and global agency inspections.
• Ability to interpret evolving regulations and apply them to processes, systems, and quality governance.
• Strong strategic thinking, risk-based decision-making, and data-driven analysis.
• Proven experience implementing global processes and driving cross-site harmonization.
• Ability to anticipate compliance risks and proactively strengthen systems and controls.
• Demonstrated ability to lead complex programs and quality initiatives across multiple sites.
• Ability to provide clear direction and influence individuals across all levels of the organization.
• Proven ability to influence across all levels of the organization without direct authority.
• Strong written and verbal communication skills.
• Effective interpersonal skills with the ability to collaborate across functions and geographies.
• Proven analytical problem-solving and conflict-resolution skills.
• Ability to work independently with a high degree of accountability and sound judgment.
• IT system development lifecycle knowledge (requirements gathering, change management, testing, implementation, continuous improvement).
• Experience defining key quality metrics, reporting metrics, analyzing trends, and applying process improvement techniques.
• Operational experience with electronic quality systems and digital compliance tools.
• Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
• Highly organized, agile, and able to manage shifting priorities in a fast-paced, dynamic environment.
• Flexible, highly motivated, with strong organizational skills and the ability to multitask with attention to detail.
• Must be able to manage critical deadlines and competing priorities effectively.
• Effective time-management skills and ability to drive results independently.
• Demonstrated alignment with Legend’s core values: Patient First, Innovation, OneTeam, Results Driven, Integrity.
• Demonstrated alignment with Legend’s core behaviors: Ownership & Commitment, Agility & Prioritization, Teamwork & Communication, Continuous Improvement.