QA Systems Lead: Quality & Compliance

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 95,000 - 125,000; Full time

Job summary

Daiichi Sankyo, Inc. in the United States, is seeking a Manager, QA System Management to lead the Quality Management System and ensure GMP compliance.

The role will author and review internal procedures, manage QA agreements with contract organizations, and oversee data integrity across critical processes. Responsibilities include CAPA oversight, Change Control, audits and vendor management, with collaboration across global QA functions to uphold regulatory requirements and product quality for

Qualifications

• Bachelor's degree in science required; advanced degree preferred.
• Minimum 4+ years in pharma/biotech with QA, compliance or audit exposure.
• Solid understanding of global cGMP requirements and quality systems.
• Experience dealing with regulatory authorities and suppliers.

Responsibilities

• Oversee QA Agreements with contract organizations to ensure GMP compliance.
• Lead Change Control system to manage proposed changes with proper QA assessment.
• Direct CAPA activities and ensure timely closure per procedures.
• Manage data from critical manufacturing steps and Annual Product Review.
• Coordinate stability studies with contract testing labs and regulatory needs.
• Develop SOPs, provide GMP training, and ensure cross-functional alignment.

Skills

Quality Management

GMP

CAPA

Change Control

Regulatory Knowledge

Vendor Management

Education

Bachelor's degree in scientific discipline

Master's degree or higher preferred

Job description

Daiichi Sankyo, Inc. in the United States, is seeking a Manager, QA System Management to lead the Quality Management System and ensure GMP compliance.

The role will author and review internal procedures, manage QA agreements with contract organizations, and oversee data integrity across critical processes. Responsibilities include CAPA oversight, Change Control, audits and vendor management, with collaboration across global QA functions to uphold regulatory requirements and product quality for