Director, GMP Quality Assurance

Oruka Therapeutics is seeking a Director of GMP Quality Assurance to provide quality oversight for clinical development programs and manufacturing. The role requires a strong background in GMP quality and manufacturing of biologics, with emphasis on external manufacturing CDMO interaction and partnership. Key responsibilities include providing GMP quality support, reviewing and approving GMP documentation, and ensuring compliance with applicable regulations and guidelines.

Requirements

• Bachelor’s degree in a scientific field with a minimum of 10 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting;
• In-depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO);
• Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers;

Benefits

• Competitive salary and benefits package
• A supportive and inclusive team environment
• Opportunities for professional growth and development