Associate Director, Quality Management System

Oruka Therapeutics•Waltham, MA

11h•Hybrid

About The Position

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. 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, Quality Management System, will report to the Director, Quality Systems. You will be responsible for providing quality oversight for Oruka’s quality management system, Veeva, document control oversight, training program management and eQMS administration. You have a strong background in Quality Systems and developing processes for clinical stage biopharmaceutical companies. Model high standards for integrity, collaboration, and accountability while being comfortable making risk-based decisions and executing with discipline in ambiguous situations. You are a hands-on, natural self-starter with strong organizational skills who thrives in a dynamic, fast-paced environment, and communicate effectively with colleagues, executive leaders, external partners, and customers.

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.

Nice To Haves

Experience supporting the onboarding and oversight of electronic GMP systems.
Prior experience contributing to the build-out or enhancement of a QMS in a development-stage company.
Experience with visual management dashboards (Excel/Smartsheet).
Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory submissions.

Responsibilities

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.