Global QMS Leader: Quality Systems & Compliance

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 119,000 - 178,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Quality Management Systems Manager to oversee the global QMS, drive continuous improvement, and ensure regulatory alignment across divisions.

The role focuses on maintaining SOPs and policies, handling CAPAs, deviations, and inspections, and guiding quality system projects for global harmonization. The position requires cross-functional collaboration and a strong track record in GxP and regulatory compliance within pharmaceutical development or manufacturing

Qualifications

• Experience managing and maintaining a Quality Management System (QMS).
• Strong knowledge of global quality policies and CAPA processes.
• Familiarity with audits/inspections and regulatory expectations.
• Ability to lead cross-functional quality initiatives and drive continuous improvement.

Responsibilities

• Support day-to-day management of the Quality Management System to ensure compliance.
• Oversee deviation, CAPA, investigation, and continuation of QMS activities.
• Coordinate with global and local quality teams to harmonize processes and policies.

Skills

Quality systems

Regulatory compliance

CAPA investigations

GxP knowledge

Cross-functional leadership

Education

Bachelor's degree in Life Sciences/Engineering/Sciences

Master's degree in Life Sciences/Engineering/Sciences

Job description

Daiichi Sankyo, Inc. is seeking a Quality Management Systems Manager to oversee the global QMS, drive continuous improvement, and ensure regulatory alignment across divisions.

The role focuses on maintaining SOPs and policies, handling CAPAs, deviations, and inspections, and guiding quality system projects for global harmonization. The position requires cross-functional collaboration and a strong track record in GxP and regulatory compliance within pharmaceutical development or manufacturing