Director, GMP Quality Assurance

Role Overview

• Provide GMP quality support and guidance for Oruka’s CMC programs, ensuring compliance with applicable GxP regulations and guidelines.
• Support the negotiation, implementation, and maintenance of quality agreements with GMP suppliers.
• Review and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation.
• Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.
• Review change controls, CAPAs, and OOS/OOT investigations in collaboration with internal and external stakeholders.
• Perform or support lot disposition activities.
• Ensure GMP quality documentation is appropriately archived and readily retrievable.
• Investigate and assess quality events such as product complaints and temperature excursions, and manage associated follow-up actions.
• Contribute to the development and maintenance of Oruka’s Quality Management System (QMS), including authoring and reviewing SOPs and quality procedures as needed.
• Review and approve clinical product labeling, ensure proper controls in place across label management lifecycle.
• Assist with the development, tracking, and reporting of GMP quality metrics and KPIs; identify trends and support continuous improvement initiatives.
• Support inspection readiness activities for both Oruka and its GMP suppliers.
• Provide GMP quality review and input for regulatory submissions and agency responses.
• Escalate quality risks and compliance issues appropriately and support risk-based decision making.
• Promote a culture of quality and continuous improvement across the organization.
• Approximately 15–20% travel (domestic and international) to GMP suppliers and Oruka offices.

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; experience in biologics is required.
• 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
• Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges.
• Excellent interpersonal and communication skills, with a strong team orientation and an ability to mentor and develop junior staff.
• Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously.
• Able to travel domestically and internationally.

Benefits

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.