Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality

Responsibilities

• Lead the commercial product quality team and ensure regulatory compliance
• Oversee CMO performance management and trend evaluations
• Serve as the primary escalation point for CMO quality issues
• Review and approve change control strategies for CMOs
• Manage deviation handling and CAPA implementation for batches
• Oversee inspection management for successful outcomes during inspections
• Work cross-functionally to support timely product commercial supply

Qualifications

• Bachelor's degree in a scientific/technical field; Master's preferred
• 8+ years in quality pharma/biotech; 6+ years with Master's
• Strong understanding of GMP and quality standards
• 4+ years of team management experience
• Proficient in MS Office applications
• Experience with small/large molecule product quality management

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) plan with potential employer match
• Flexible spending accounts (FSA/HSA)
• Life insurance and wellness programs
• Paid time off and employee stock purchase plans