Global QMS Director: Inspection-Ready & Excellence

Corbus Pharmaceuticals, Inc.; Norwood (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Corbus Pharmaceuticals Holdings, Inc. is seeking a Director/Associate Director, Quality Management Systems to lead global QMS activities, including document control, training, deviations, CAPA, and change control.

The role partners across functions to ensure inspection readiness and compliant, scalable quality programs. The candidate will drive continuous improvement, support regulatory inspections, and help establish robust QMS governance while embedding quality into business processes.

Qualifications

• Requires degree-level education in life science and 10+ years in GxP biotech/pharmaceuticals.
• Experience leading global QMS programs including Document Control, Deviation/CAPA, Change Control and Risk Management.
• Strong understanding of regulatory expectations and inspection readiness across FDA/MHRA/EMA.
• Proven ability to develop and implement training curricula and role-based training programs.
• Expertise in SOP development, document authoring, revision, and governance processes.

Responsibilities

• Lead and continuously improve Quality Systems, including Document Control, Training, CAPA, Deviations, Change Control and Risk Management.
• Oversee lifecycle management of quality documents and related records for compliance and inspection readiness.
• Lead design and implementation of learning programs and refresher training across functions.
• Support Deviations, CAPA, Change Controls and Risk Management with hands-on leadership as needed.
• Partner with cross-functional stakeholders to embed quality into business processes and decision-making.
• Support QMR process, monitor system health, identify trends and drive improvements.

Skills

QMS Leadership

Regulatory Knowledge

Cross-functional Collaboration

SOP Writing

Training & Curriculum

Education

Life science degree (BSc/MSc/PhD)

Tools

Veeva Suite

MS Office

Job description

Corbus Pharmaceuticals Holdings, Inc. is seeking a Director/Associate Director, Quality Management Systems to lead global QMS activities, including document control, training, deviations, CAPA, and change control.

The role partners across functions to ensure inspection readiness and compliant, scalable quality programs. The candidate will drive continuous improvement, support regulatory inspections, and help establish robust QMS governance while embedding quality into business processes.