Senior Labeling Program Lead (Regulatory & QA)

Kite Pharma; Santa Monica (CA); On-site; USD 107,000 - 139,000; Full time

Job summary

Kite Pharma, a Santa Monica-based biopharmaceutical company, is seeking an experienced labeling expert to join Regulatory Affairs and Packaging teams. The role focuses on FDA‑regulated labeling operations, cGMP compliance, and cross‑functional collaboration to drive accurate label design and implementation across sites.

You will lead complex labeling projects, review templates, author SOPs, and ensure timely, compliant labeling changes while partnering with Manufacturing, QA, and Legal to meet

Qualifications

• At least 5 years of relevant experience with a BS/BA degree, or at least 4 years with an MS degree; pharmaceutical labeling experience preferred.
• Strong knowledge of FDA regulations, cGMP requirements, and regulatory guidance documents.
• Experience leading complex cross-functional labeling projects and stakeholder management.
• Excellent verbal communication and technical writing skills; ability to develop SOPs and adhere to timelines.
• Proficiency with Microsoft Office applications and ability to work in evolving environments.

Responsibilities

• Serve as a labeling subject matter expert and provide guidance across Regulatory Affairs, Legal, Package Engineering, Quality Assurance.
• Label Template Review and Approval review and approve label design templates
• Lead and support labeling projects requiring independent judgment and innovative problem-solving.
• Manage cross-functional labeling implementation activities to ensure timely changes.
• Coordinate the implementation of new labeling with Materials Management and multiple sites.
• Drive completion of complex labeling processes by collaborating with stakeholders and ensuring regulatory compliance.
• Develop process improvements based on novel labeling approaches and workflows.
• Author, revise, and improve systems, procedures, and SOPs to enhance labeling efficiency and compliance.
• Ensure labeling activities comply with FDA regulations, cGMP, and regulatory guidance.
• Facilitate cross-functional alignment to resolve labeling issues and support implementation.
• Support continuous improvement initiatives focused on labeling accuracy and operational excellence.

Skills

Labeling expertise

FDA regulations knowledge

Cross-functional leadership

Project management

Technical writing

Verbal communication

Education

BS/BA in life sciences

MS degree in related field

Tools

Microsoft Office

Job description

Kite Pharma, a Santa Monica-based biopharmaceutical company, is seeking an experienced labeling expert to join Regulatory Affairs and Packaging teams. The role focuses on FDA‑regulated labeling operations, cGMP compliance, and cross‑functional collaboration to drive accurate label design and implementation across sites.

You will lead complex labeling projects, review templates, author SOPs, and ensure timely, compliant labeling changes while partnering with Manufacturing, QA, and Legal to meet