Senior Director of Quality

Job Summary

To provide strategic CMC and quality regulatory guidance for biotechnology and pharmaceutical clients, the remote Senior Director of Quality will lead global regulatory strategies, oversee submission preparations, and mentor regulatory professionals while supporting client engagement.

Key responsibilities

• Lead global CMC regulatory strategies for development, registration, and post-approval programs
• Serve as a trusted advisor on regulatory pathways, submission planning, and health authority interactions
• Collaborate with quality, manufacturing, and development teams to ensure regulatory compliance and execution

Required qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred
• 15+ years of experience in Regulatory Affairs, CMC, Quality, biotechnology, pharmaceuticals, or a related field
• Extensive knowledge of FDA regulations, global regulatory requirements, and CMC submission strategies
• Experience supporting biologics, small molecules, and novel therapeutic platforms across the product lifecycle
• Proven leadership experience managing regulatory teams and serving as a client-facing strategic advisor