Associate Director, External Supplier QA GMP

Job Summary

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Responsibilities

• First-hand knowledge of drug manufacturing, packaging, QA, compliance and audit
• Experience with bio manufacturing and technical transfer
• Direct experience dealing with multinational drug regulators
• Previous management experience preferred
• Solid understanding of quality management and continuous process improvement principles including global cGMP requirements
• Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications
• Experience with contract manufacturing organizations

Qualifications

• Bachelor's Degree in scientific discipline required or Master's Degree or other advanced degree preferred
• Experience Qualifications: 7 or more years in pharmaceutical and/or biological operations; 4 or more years direct experience dealing with multinational drug regulators; Experience with Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications; Experience dealing with contract manufacturing organizations

Education Qualifications

Bachelor's Degree in scientific discipline required or Master's Degree or other advanced degree preferred