Director, Product Quality Lead (Pharmaceuticals)

TL;DR

Director, Product Quality Lead (Pharmaceuticals): Driving product quality excellence across late-stage clinical and commercial oncology programs with an accent on regulatory compliance and quality risk management. Focus on embedding compliance into development and manufacturing while influencing critical decisions on patient safety and global market access.

Location: Remote (United States)

Salary: $172,000 – $232,000

Company

A global oncology-focused organization dedicated to improving access to life-saving medicines worldwide.

What you will do

• Lead global product quality strategy for late-phase clinical and commercial programs to ensure regulatory compliance.
• Act as a Subject Matter Expert in quality risk management, investigations, and CMC regulatory content review.
• Partner with R&D, CMC, manufacturing, and regulatory teams to integrate quality considerations into the product lifecycle.
• Implement and enhance Quality Risk Management frameworks aligned with ICH Q9.
• Drive product quality performance monitoring, trend analysis, and continuous improvement initiatives.
• Mentor team members and represent the quality organization in governance forums and audits.

Requirements

• Bachelor's degree with 8+ years of experience (or Master's with 10+ years) in quality sciences or regulated industries like pharma or biotech.
• 5+ years of managerial or leadership experience managing teams or cross-functional initiatives.
• Strong expertise in FDA and EMA regulatory frameworks and ICH Q9 risk management methodologies.
• Proficiency in root cause analysis, Lean, Six Sigma, and related quality tools.
• Must be based in the United States.
• Willingness to travel up to 20%.

Culture & Benefits

• Competitive annual salary with bonus eligibility and incentive compensation.
• Discretionary equity awards and employee stock purchase plan.
• Comprehensive medical, dental, vision, life insurance, and wellness programs.
• 401(k) retirement plan with additional financial options like FSA/HSA.
• Paid time off and flexible leave policies.
• Strong emphasis on continuous learning, leadership development, and global career opportunities.