Global QMS Manager - Quality & Compliance Lead

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 119,000 - 178,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Manager, Quality Management Systems in New Jersey to lead the global QMS strategy, maintain policies, and drive continuous improvement across development and manufacturing.

You will partner with global quality teams, oversee CAPA, deviations, change control, document management, and support audits and regulatory inspections.

The role requires 4+ years in QMS with GxP experience and a strong leadership record.

Qualifications

• 4+ years of professional experience managing and maintaining the Quality Management System
• Experience identifying, triaging, escalating and monitoring quality issues and investigations
• Ownership of global Quality System procedures (e.g., Change Control, Deviation, CAPA, Document Management)
• Collaboration with local and global Quality teams to harmonize policies and practices
• Experience with drug development and/or commercial Quality systems across modalities
• GxP knowledge and leadership across functions with regulatory alignment

Responsibilities

• Support all aspects of the Quality Management System to ensure compliance and process effectiveness
• Provide proactive oversight of the Quality System for ongoing development activities and adherence to regulations
• Foster a Quality Mindset and culture focused on delivering results across functions

Skills

QMS management

Regulatory compliance

Cross-functional collaboration

CAPA & Deviations

Audit readiness

Education

Bachelor's Degree in Life Sciences/Engineering/Sciences

Master's Degree preferred

Job description

Daiichi Sankyo, Inc. is seeking a Manager, Quality Management Systems in New Jersey to lead the global QMS strategy, maintain policies, and drive continuous improvement across development and manufacturing.

You will partner with global quality teams, oversee CAPA, deviations, change control, document management, and support audits and regulatory inspections.

The role requires 4+ years in QMS with GxP experience and a strong leadership record.