Senior Director of Quality

About the role

Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to join a leading regulatory consulting and drug development services organization. The Senior Director, Quality & CMC Regulatory Strategy will provide strategic CMC and quality regulatory guidance to biotechnology and pharmaceutical clients, supporting products from early development through commercialization and lifecycle management.

Responsibilities

• Lead global CMC regulatory strategies for development, registration, and post-approval programs.
• Serve as a trusted advisor to clients on regulatory pathways, submission planning, and health authority interactions.
• Oversee the preparation and review of INDs, amendments, global filings, and lifecycle management submissions.
• Collaborate with quality, manufacturing, and development teams to ensure regulatory compliance and execution.
• Mentor regulatory professionals while supporting client engagement and business growth initiatives.

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.

Pay

Salary Range: $250,000 – $290,000

Benefits

• Medical, Dental, Vision
• Paid Time Off
• 401(k)
• Additional company-sponsored benefits