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.
Support cross-functional collaboration and drive process improvements to enhance the organization's approach to quality governance.
Collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture.
Manage Product Quality Network teams responsible for deliverables for multiple late-phase clinical or commercial programs.
Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.
Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.

Requirements

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 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)

Benefits

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality risk managementtechnical training programsprocess improvementsregulatory complianceknowledge-sharing strategiesstatistical modelingproduct quality governancenew product developmentlifecycle managementmanagerial experience

Soft Skills

cross-functional collaborationleadershipcommunicationteam managementorganizational skillsproblem-solvingstrategic thinkingcontinuous improvementknowledge sharingresource allocation