Associate Director, QMS Process Improvement and Analytics

Overview

Employer Industry: Biotechnology

Why consider this job opportunity:

• Salary up to $189,900 annually
• Eligible to participate in an annual bonus plan and an incentive compensation plan
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
• Opportunity for career advancement and growth within the organization
• Work in a collaborative environment focused on continuous improvement and digital transformation
• Chance to make a meaningful impact in the fight against cancer

• Oversee and enhance the Quality Management System (QMS) processes to ensure compliance and efficiency
• Collaborate with QMS Process Owners and teams to define and analyze key performance indicators (KPIs)
• Support governance meetings by communicating risks, trends, and required actions regarding QMS processes
• Lead cross-functional improvement projects to streamline QMS workflows and enhance user experience
• Ensure audit readiness by maintaining complete and accessible QMS documentation and records

• Bachelor’s degree and 8+ years of progressive quality leadership experience
• 5 years of managerial experience directly managing people or leading teams and projects
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH Q10, ISO 9001/13485)
• Hands-on experience with QMS processes such as Deviation Management, Complaint Handling, and CAPA
• Excellent technical writing, communication, and analytical skills

• Master’s degree with 6+ years of progressive quality leadership experience
• Certification or training in Lean, Six Sigma, or similar process improvement methodology
• Experience with electronic QMS systems and digital quality tools
• Advanced user of Smartsheet for project tracking and collaboration
• Proven ability to lead process improvement initiatives

#Biotechnology #Quality Management #Career Opportunity #Competitive Pay #Continuous Improvement

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