QA System Leader: GMP Compliance & Vendor Oversight

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 127,000 - 191,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Manager, QA System Management to oversee the Quality Management System (QMS) and ensure GMP compliance in alignment with regulatory requirements.

This role focuses on document control, data integrity, and development of global quality procedures. The candidate will author and review internal SOPs, manage QA Agreements with contract organizations, and lead vendor qualification efforts.

Qualifications

• Bachelor's degree in scientific discipline required; or advanced degree preferred.
• 4+ years in pharmaceutical/biopharma QA, GMP, or related operations.
• Experience with MA/QA agreements, regulatory inspections, and vendor qualification advisable.

Responsibilities

• Lead QA System Management activities to ensure GMP compliance and data integrity.
• Develop, author, review internal procedures to harmonize global quality standards.
• Create and review Quality Assurance Agreements with contract organizations.
• Manage vendor qualification program and QA Agreement system.
• Compile data for Annual Product Reviews; oversee stability study programs.
• Develop Standards and Procedures (SOPs) and provide related training.
• Collaborate cross-functionally to align processes across regions and functions.

Skills

Quality Management

Regulatory Compliance

GMP

Change Control

CAPA

Data Management

Document Management

Vendor Qualification

QA Systems

Audit

Education

Bachelor's Degree in scientific discipline

Tools

SOP Authoring

Quality Metrics

Job description

Daiichi Sankyo, Inc. is seeking a Manager, QA System Management to oversee the Quality Management System (QMS) and ensure GMP compliance in alignment with regulatory requirements.

This role focuses on document control, data integrity, and development of global quality procedures. The candidate will author and review internal SOPs, manage QA Agreements with contract organizations, and lead vendor qualification efforts.