Associate Director, Quality Management System

Role Overview

• Primary owner of QMS infrastructure and electronic systems.
• Provide oversight of document control processes, including creation, review, approval, and lifecycle management of policies, SOPs, and forms.
• Manage training program, including creation, assignment, and tracking of training; onboarding and GMP refresher training; and maintenance of training curricula.
• Administer the electronic Quality Management System (eQMS), including system implementation, validation, and management of periodic releases.
• Oversee the deviation process for compliance, ensuring appropriate documentation and adherence to procedures.
• Review and oversee CAPAs to ensure process compliance and effectiveness of corrective and preventive actions.
• Administer change control system and manage departmental changes.
• Coordinate product complaint processing.
• Review and approve GMP documentation, as requested.
• Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.
• 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.
• 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 8 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

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