Director, Product Quality Lead(m/w/x)

Description

You will drive global quality excellence by leading cross-functional teams, managing risk frameworks, and mentoring staff to ensure the company's products meet the highest regulatory standards.

Requirements

• •Bachelor’s degree and 8+ years experience
• •Master’s degree and 10+ years experience preferred
• •5+ years managerial or leadership experience
• •Strong PC literacy and MS Office skills
• •Experience in statistical modeling software
• •Advanced degree in relevant field
• •Extensive experience leading quality investigations
• •Expertise in quality systems and regulations
• •Strong leadership and problem-solving skills
• •Experience developing global training programs
• •Proficiency in quality tools and methodologies
• •Effective communication across business functions
• •Willingness to travel up to 20%

Tasks

• •Represent the quality organization in molecule-level governance meetings
• •Facilitate quality risk assessments and complex investigations
• •Review regulatory CMC submission content for accuracy
• •Manage product quality network teams for clinical and commercial programs
• •Embed quality considerations into new product development and lifecycles
• •Advise on CMC strategies and quality risk management for commercialization
• •Monitor product quality performance to identify and drive improvements
• •Lead cross-functional teams to enhance global quality systems
• •Implement Quality Risk Management frameworks following ICH Q9 standards
• •Support regulatory inspections and audits against global standards
• •Mentor team members to develop product quality and leadership skills
• •Analyze emerging scientific trends and their impact on products

Tools & Technologies