Associate Director, GxP Compliance and Auditing

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.
• 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: 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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• The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
• Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
• Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D 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 voluntary 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 full-time employees. Contractors are not eligible for benefits through Legend Biotech.
• Work Authorization & Employment Eligibility
• Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.
• 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.