The Product Quality Lead will play a critical role in advancing global quality initiatives, ensuring the highest standards of product quality, and fostering expertise in emerging quality technologies.
This position will contribute to quality risk management, knowledge-sharing strategies, and the development of technical training programs to strengthen compliance, operational excellence, and innovation.
The PQL will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance.
Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.
Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability.
Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.
Actively mentoring new and existing team members to develop core Product Quality skills and leadership skills.

Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)
Master’s degree and 10+ years of experience preferred
5+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Experience in statistical modeling software (Mintab, JMP, Tableau, SciLab)

Director, Product Quality Lead

Key skills