Associate Director, BPO Global APQR & Product Data Quality

Employer Industry: Biotechnology

• Salary up to $193,400 annually
• Eligible for annual bonus and incentive compensation plan
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
• Opportunity to own shares in the employer through discretionary equity awards and Employee Stock Purchase Plan
• Collaborative work environment with a focus on continuous improvement and professional growth
• Chance to make a meaningful impact in the fight against cancer

• Own and oversee the Global APQR process, ensuring product quality performance and driving improvements
• Collaborate with R&D, manufacturing, and regulatory teams to integrate quality considerations in product development
• Manage change tracking and implementation related to Regulatory CMC commitments
• Lead or participate in cross-functional teams to enhance quality systems and resolve systemic challenges
• Support regulatory inspections and audits to maintain compliance with global quality standards

• Bachelor’s degree and 6+ years of experience in quality sciences, quality systems, or related fields within a regulated industry
• 3 years of managerial experience directly managing people or leading teams/projects
• Strong PC literacy, including proficiency in MS Office and ability to learn specialized platforms
• Expertise in quality systems, regulatory requirements, and risk management frameworks
• Strong leadership and problem‑solving skills, with an ability to communicate complex information effectively

• Master’s degree and 8+ years of experience in a relevant field
• Extensive experience in leading quality investigations and implementing new technologies
• Proficiency in quality tools and methodologies such as Lean and Six Sigma
• Experience in developing global training programs and fostering SME networks
• Advanced degree in life sciences or quality management

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