Associate Director, GxP Compliance and AuditingRole OverviewThe Associate Director, GxP Compliance and Auditing, serves as the strategic leader for the development, implementation, and continuous enhancement of Legend Biotech's global GxP compliance and auditing programs. This role oversees all core elements of the compliance framework, including internal and externa audits, inspection readiness and logistics, supplier quality management, regulatory intelligence monitoring and dissemination, Quality Management Review oversight, and quality planning activities. Based in Bridgewater, this people-manager position oversees one direct report and is responsible for conducting internal audits at the Somerset and Raritan CARVYKTI sites, performing external third-party and supplier audits, and routinely supporting inspection readiness and related compliance activities across the Somerset and Raritan manufacturing facilities with on-site travel expected.
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 (SomLead the Internal Audit Program for Somerset and Raritan-CARVYKTI to ensure compliance with Legend policies, procedures, and cGxP requirements. • Generate and execute the annual internal and external audit schedules.
- Provide management with recommendations based on internal and external audit results.
- Establish and maintain cGxP compliance audit trends and metrics.
- Manage and execute external audit programs, including vendor and third-party audits.
- Oversee external audits, vendor audits, and related audit activities.
- Oversee GxP quality audits of Legend suppliers; prepare, approve, and distribute audit reports.
- Manage audit outcomes, including CAPAs and regulatory responses.
- Perform vendor risk assessments to determine and evaluate audit frequency.
- Oversee supplier qualification, approval, and risk assessment processes.
- Execute supplier qualification activities for Somerset and Raritan-CARVYKTI.
- Develop and implement audit strategies and plans (e.g., Qualification of Apheresis Centers)
- Annual Environmental Social Governance Reporting Stewardship.
- Lead regulatory intelligence activities and monitor emerging regulations; oversee the cross-functional Regulatory Intelligence Program to identify applicable regulatory changes and establish implementation timelines and actions for Legend.
- Execute the GxP Regulatory Intelligence Program, including impact assessments, maintenance, routine dissemination to stakeholders, publication, and intranet site maintenance for Somerset and Raritan-CARVYKTI.
- Oversee and execute the Quality Systems Management Review Program (QSMR), working cross functionally to identify key quality metrics that monitor product quality, quality systems, compliance sustainability and drive continuous improvement and actions.
- Drive/coordinate Quality Planning.
- Build cross-functional partnerships to strengthen compliance culture.
- Provide QA advice to stakeholders (e.g., manufacturing, CROs, CMOs) based on analyses and interpretation of cGxP regulations.
- Establish key stakeholder relationships with Global and Site Quality functions, Manufacturing operations and Suppliers.
- Ability to interact and influence all levels within the organization to achieve compliance.
- Maintain cGxP related quality system SOPs in compliance with all applicable regulatory requirements to align with existing company policies.
- Ownership of Compliance-Aligned Quality Documents at Bridgewater and Somerset.
- Support Annual Environmental Social Governance Reporting activities.
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 hosting regulatory inspections and leading enterprise-level compliance programs. Experience in aseptic manufacturing facility, biologics, or advance therapies strongly preferred, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Experience working across all GxP functions (GMP, GDP, GCP, GLP) preferred.
- Knowledge of GxP requirements for quality systems and processes that enable compliance.
- Deep expertise in global GxP regulations and quality compliance frameworks, including: o 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.
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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. 
