Associate Director/ Director of Quality Systems Management

2 weeks ago

Menlo Park, United States Oruka Tx Full time

Associate Director/ Director of Quality Systems Management

About Us:

Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. 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 a Program Management leader who is 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. Position Overview: 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 candidate will support GMP activities at CDMOs. 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. Key Responsibilities: 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. CDMO Oversight:

Provide quality oversight of CDMO quality-related deviations, changes, and CAPAs. Support management and facilitation of site review boards for change control and deviations. Facilitate investigations of external deviations and coordinate the reviews and approvals. Strategic Reporting:

Develop tools and compile metrics for reporting to management. Qualifications: BS in Life Sciences with a minimum 10-12 years of experience in a cGMP environment with a strong knowledge of FDA and EMA regulations OR Advanced degree with a minimum 8-10 years of experience in a cGMP environment. 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. Excellent organizational tools. Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively. What We Offer: 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. Flexible work arrangements – opportunity for hybrid work between home and our Boston Area office. A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work. Opportunities for professional growth and development. We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day. Are you currently fully eligible to work in the United States of America?

* -- Do you now or will you, at a future date, require visa sponsorship to work in the United States?

* -- If not located in the San Francisco Bay Area or Boston Area, are you open to relocation?

* --

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