Associate Director/Director of Quality Systems Management

4 weeks ago


Boston MA, United States Oruka Therapeutics Full time

Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We have a lead program that we expect will be in the clinic in 2025 and could offer transformative efficacy for a disease that affects millions of people. As we build our core team, we're seeking our first Executive Assistant who is not just looking for a job, but an opportunity to be part of something bigger. The successful candidate will be a key leader within the quality organization. The individual will be responsible for the Quality Management System (QMS) including the vendor management program, Risk management program, Good Documentation Program, Training program, and development of Quality Policies and management of controlled documents. The role will interface closely with other cross-functional groups such as Clinical Operations, Clinical Pharmacology, CMC, Non-Clinical Development, Regulatory Affairs, and Supply Chain.

QMS Setup and Leadership: Develop the document control strategy for the company and support the selection, implementation, and management of the QMS enterprise system for vendor qualification, vendor management, risk management, deviation and change control.
Records Management and Training: Develop and manage controlled documents and training records. Support creation of an onboarding and phase appropriate training program.
Provide quality oversight of CDMO quality-related deviations, changes, and CAPAs. Support management and facilitation of site review boards for change control and deviations. Develop tools and compile metrics for reporting to management.

Ability to manage multiple tasks within a GxP environment, with minimal oversight is required.
Experience in establishing pre-clinical and GMP operations and systems is beneficial.
Flexible work arrangements – opportunity for hybrid work between home and our Boston Area office.



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