Associate Director, GMP Quality Assurance

Associate Director, GMP Quality Assurance

Remote;
Waltham, Massachusetts, United States

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.

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As we build our core team, we’re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

The Associate Director of GMP Quality Assurance will report to the Senior Director of GMP Quality. As the Associate Director of GMP Quality Assurance, you will be responsible for providing quality oversight for Oruka’s clinical development programs and manufacturing. You will be responsible to ensure Oruka’s programs are advanced through the development pipeline in compliance with phase-appropriate regulatory requirements, applicable guidelines, and industry best practices.

You have a strong background in GMP quality and manufacturing of biologics, with an emphasis on external manufacturing CDMO interaction and partnership. You should have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a development environment. You are a hands on, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and external partners and customers.

• 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 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, ensuring 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.

• 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…