Associate Director/Director, Quality Control

About Us: 

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. For more information, visit www.orukatx.com

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.  

Job Title: Associate Director/Director, Quality Control

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.

Role Overview:

The Associate Director/Director of Quality Control (QC) is responsible for providing quality control strategy, support, and oversight within a Phase 2 GMP biopharmaceutical manufacturing environment focused on monoclonal antibody production. This role ensures that all analytical testing, raw material and in-process controls, method qualification and execution, release activities, and stability programs are executed in compliance with current Good Manufacturing Practices (cGMP), regulatory expectations, and internal quality standards. The Associate Director/Director will partner closely with CMC, Quality Assurance, Upstream/Downstream Process Development, Analytical Development, Supply Chain, Clinical Operations, and Regulatory Affairs to support clinical supply, development of phase-appropriate QC Oversight Procedures and Processes, and future commercial readiness.

Key Responsibilities:

• Analytical Testing Oversight: Provide quality oversight of contract organization analytical testing, release testing, stability testing, microbiology, raw material release, and environmental monitoring programs. Participate in supplier qualification audits, due diligence site visits, and QC person-in-plant execution as needed.  Facilitate investigations for out-of-specification and/or out-of-trend results, external deviations, product complaints, and coordinate the necessary reviews and approvals.  Oversee qualification, validation, and lifecycle management of analytical methods used to test monoclonal antibody products.  Support tech transfer of analytical methods.  Establish relationships with contract manufacturing and testing organizations through on-site support (travel 20-25%).
• Establish a Robust Internal QC Infrastructure: Provide leadership to execute scaling QC capabilities for future late-phase/commercial manufacturing needs. Manage external testing laboratories, stability programs, specifications, analytical methods, reference standards, and critical reagents programs.  Develop phase-appropriate internal QC procedures and processes as pipeline continues to mature.  Own and manage Oruka LIMS system.  Establish and manage QC-related metrics.
• Ensure Uninterrupted Clinical Supply: Drive deviation investigations, out-of-specification (OOS) and out-of-trend (OOT) analysis, CAPA implementation, and change control within QC. Leverage stability data to project shelf-life of both DS and DP supply through trending analysis.  Manage product expiration dates and expiry extensions. Ensure timely review, approval, and trending of QC data to support product batch disposition and regulatory compliance.
• Support Clinical Program Advancement: Own QC-related regulatory submission content (e.g., IND amendments) and represent QC during audits and regulatory inspections. Contribute to scaling QC capabilities for future late-phase/commercial manufacturing needs.

Qualifications:

Required

• Bachelor’s degree in Life Sciences (e.g., Biochemistry, Biology, Chemistry) or related discipline; advanced degree preferred.
• 8+ years of experience in QC or analytical sciences within biopharmaceutical GMP environments, including monoclonal antibody testing.
• Experience in building and managing a QC team or group
• Proven experience in successfully standing up and managing contract laboratory vendors, including interfacing with new labs and negotiating quality agreements
• In depth knowledge of cGMP, FDA/EMA regulations, and applicable gu