Strategic QA Lead: External Suppliers & GMP Compliance

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 153,600 - 230,400; Full time

Job summary

Daiichi Sankyo US is seeking a Quality Assurance Lead to oversee Contract Manufacturing compliance in Basking Ridge, New Jersey. The successful candidate will be responsible for ensuring that all contracted organizations comply with FDA regulations and internal quality standards.

The role involves managing quality systems, participating in cross-functional teams, and supporting investigations related to quality deviations. A Bachelor's in a scientific discipline, along with substantial experience in pharmaceutical operations, is required.

The position offers a salary range of USD$153,600.00 - USD$230,400.00 based on qualifications.

Qualifications

• 7+ years in pharmaceutical/biological operations.
• Experience with drug manufacturing and compliance.
• Solid understanding of cGMP requirements.

Responsibilities

• Lead QA assessments for Contract Manufacturing Organizations.
• Ensure robust Quality Management System compliance.
• Manage investigations for deviations and complaints.

Skills

Quality Management

Drug Manufacturing

Aseptic/Sterile Manufacturing

Regulatory Compliance

Continuous Process Improvement

Education

Bachelor's Degree in Scientific Discipline

Job description

Daiichi Sankyo US is seeking a Quality Assurance Lead to oversee Contract Manufacturing compliance in Basking Ridge, New Jersey. The successful candidate will be responsible for ensuring that all contracted organizations comply with FDA regulations and internal quality standards.

The role involves managing quality systems, participating in cross-functional teams, and supporting investigations related to quality deviations. A Bachelor's in a scientific discipline, along with substantial experience in pharmaceutical operations, is required.

The position offers a salary range of USD$153,600.00 - USD$230,400.00 based on qualifications.