Associate Director, QMS Process Improvement and Analytics

Why consider this job opportunity:

• Salary up to $189,900 annually
• Eligible for annual bonus and discretionary equity awards
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, and Paid Time Off
• Opportunity for career advancement and growth within a leading biotechnology organization
• Work in a collaborative environment focused on improving quality management systems in the fight against cancer

• Oversee and enhance the execution of the Quality Management System (QMS) processes
• Collaborate with stakeholders to define and analyze key performance indicators (KPIs) to enhance process performance
• Support internal and external audit readiness by maintaining complete and accessible QMS documentation
• Lead cross-functional projects aimed at streamlining QMS workflows and improving user experience
• Contribute to the digital transformation of QMS processes through the implementation of automation and analytics tools

• Bachelor’s degree and 8+ years of progressive quality leadership experience
• 5 years of managerial experience directly managing people or leading teams/projects
• Strong working 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
• Proficiency in MS Office and experience with electronic QMS systems

• Master’s degree and 6+ years of progressive quality leadership experience
• Certification or training in Lean, Six Sigma, or similar process improvement methodologies
• Advanced user of Smartsheet for project tracking and collaboration
• Demonstrated ability to lead process improvement initiatives effectively

#Biotechnology #Quality Management #Career Opportunities #Competitive Pay #Health Care Innovation

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