Associate Director, BPO Global APQR & Product Data Quality

Overview

Employer Industry: Biotechnology

• Salary up to $193,400 annually
• Eligible for annual bonus plan and incentive compensation plan
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
• Opportunities for career advancement and leadership development
• Supportive work culture that values collaboration and innovation

• Own the Global APQR process to monitor product quality performance and drive improvements
• Collaborate with R&D, manufacturing, and regulatory teams to ensure quality in product development
• Manage change tracking and implementation for Regulatory CMC commitments
• Lead or participate in cross-functional teams to enhance quality systems
• Support regulatory inspections and audits, ensuring compliance with global quality standards

• Bachelor’s degree and 6+ years of experience in quality sciences or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology)
• 3 years of managerial experience directly managing people or leading teams
• Strong PC literacy and proficiency with MS Office
• Extensive experience in leading quality investigations and implementing new technologies
• Expertise in quality systems and regulatory requirements (e.g., FDA, EMA)

• Master’s degree and 8+ years of experience in quality sciences or related fields
• Advanced degree in life sciences or quality management
• Experience in developing and delivering global training programs
• Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma)
• Ability to communicate complex information clearly across business functions

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