Legend Biotech US
Associate Director, Site Quality Compliance Lead
Raritan, New Jersey, United States · Director
Sponsorship not specifiedDetected 12 days ago
ComplianceAuditingCadenceGMPLeadershipCommunicationCollaborationInternal AuditGxP
About the role
- The leader models Legend's core values-Patient First, Innovation, OneTeam, Results Driven, and Integrity-and core behaviors of Ownership & Commitment, Agility & Prioritization, Teamwork & Communication, and Continuous Improvement.
- This position represents the Raritan site on behalf of Legend Biotech in global forums, regulatory inspections, and cross-site/global quality initiatives.
Responsibilities
- Maintain ownership of quality compliance-aligned Legend documents including policies, SOPs, WIs, and ensure alignment with global/regulatory requirements.
- Lead Quality Planning activities (Raritan-CARVYKTI-Legend) and ensure alignment with enterprise quality objectives.
- Manage multiple compliance-related projects with agility, prioritization, and strong organizational discipline.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
- Drive continuous improvement.
- Identify and manage resource needs to support growing organization and operational needs in alignment with evolving business priorities.
- Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional departments.
- Lead Raritan site quality compliance and regulatory processes in a GMP manufacturing environment.
- Develop and maintain a turn-key inspection management program and align with other Legend sites, as necessary.
- Ensure and maintain a state of inspection readiness.
Compensation
- Support quality systems activities including annual product review, site risk register, and internal quality agreements.
Benefits
- Oversee compliance health monitoring, risk assessments, and performance metrics to proactively identify and mitigate risks.
- Coordinate front room/ back-room activities for health authority inspections and independent audits.
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This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.