Global QMS Director: Inspection-Ready Excellence

Corbus Pharmaceuticals Inc; Norwood (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Corbus Pharmaceuticals Holdings, Inc. in the Boston area seeks a Director/Associate Director of Quality Management Systems to own the global QMS, including document control, records management, training, deviations, CAPA, change control and risk management, ensuring inspection-ready, scalable systems.

This hands-on leadership role requires strategic vision and operational execution, partnering across functions to embed quality as a driver of business performance and supporting continuous

Qualifications

• 10+ years of experience in GxP biotech/pharma quality systems
• Experience with eQMS oversight and validation
• Knowledge of FDA/MHRA/EMA regulatory requirements
• Strong communication and documentation skills
• Proven ability to lead cross-functional teams across regions

Responsibilities

• Lead and maintain Quality Systems across Document Control, Records, Training, CAPA, Deviations, Change Control and Risk Management
• Ensure inspection readiness and regulatory compliance for global operations
• Oversee eQMS validation, maintenance and lifecycle management
• Collaborate with cross-functional stakeholders to embed quality into business processes
• Prepare for regulatory inspections and audits and support continuous improvement

Skills

QMS ownership

Document control

CAPA management

Change control

Risk management

Regulatory compliance

Leadership

Cross-functional collaboration

eQMS validation

Veeva proficiency

Education

Life sciences degree

Tools

Veeva

MS Office

Job description

Corbus Pharmaceuticals Holdings, Inc. in the Boston area seeks a Director/Associate Director of Quality Management Systems to own the global QMS, including document control, records management, training, deviations, CAPA, change control and risk management, ensuring inspection-ready, scalable systems.

This hands-on leadership role requires strategic vision and operational execution, partnering across functions to embed quality as a driver of business performance and supporting continuous