Senior Director, Quality

About the role

A global biopharmaceutical manufacturer is seeking a Senior Director, Quality to lead Quality Operations across the U.S. organization. This individual will provide leadership across Quality Assurance, Quality Control, Quality Compliance, Product Release, Supplier Quality, and Regulatory Inspection Readiness while serving as a key member of the site leadership team.

Responsibilities

• Lead QA, QC, Quality Compliance, Product Release, and Supplier Quality functions
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality standards
• Oversee site quality systems including deviations, CAPAs, change controls, complaints, and audits
• Lead FDA inspections, customer audits, and regulatory interactions
• Drive quality culture, continuous improvement, and operational excellence initiatives
• Partner with manufacturing and site leadership to support business objectives while ensuring patient safety and product quality
• Develop and mentor quality leadership teams

Requirements

• 15+ years of pharmaceutical GMP experience
• Progressive leadership experience within Quality Assurance and Quality Operations
• Experience leading FDA inspections and regulatory interactions
• Strong background overseeing Quality Systems, Compliance, and Product Release
• Prior leadership responsibility for QA and QC organizations
• Proven success leading large cross-functional teams in commercial pharmaceutical manufacturing environments

Preferred Qualifications

• Senior Director, Director, VP Quality, or Head of Quality experience
• Sterile, biologics, vaccines, or highly regulated pharmaceutical manufacturing experience
• Experience managing complex quality organizations and regulatory initiatives