Job Summary

A company is looking for a Product Quality Leader Director.

Key Responsibilities:

• Participate in CMC team meetings and provide technical quality expertise to influence global strategies and ensure robust implementation plans for product/program changes
• Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
• Own and manage the product quality risk register and ensure timely resolution, mitigation, and escalation of product quality issues and risks

Required Qualifications:

• BA/BS in life sciences or related field required, advanced degree desirable
• 12+ years of experience in biotechnology, pharmaceutical, or highly regulated industry
• Experience with gene therapy or biologics product development and licensure preferred
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Prior experience in regulatory, quality, compliance, or a combination of technical experience