Director, Quality Control

About the role

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: Director, Quality Control Location: Hybrid - Waltham, MA or Menlo Park, CA. Candidates will be required to be in-office 3 days/week Open to remote for non-local candidates. Role Overview: The Director, Quality Control - Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. This role will ensure timely, compliant, and scientifically sound oversight of release, stability, characterization, in-process, and method lifecycle activities performed at CMOs and contract testing laboratories. This role is responsible for ensuring that all QC systems, analytical methods, and testing programs are inspection-ready and aligned with global regulatory expectations for commercial biologics. The Director will partner cross-functionally and externally to enable successful PPQ execution, analytical method validation, regulatory approval, and commercial launch readiness.

Responsibilities

• QC Strategy, Clinical Execution & Commercial Readiness
• Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.
• Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.
• Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.
• Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.
• Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.
• Analytical Methods, Validation & Lifecycle Management
• Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.
• Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.
• Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.
• Drive continuous improvement of analytical control strategies and testing programs through data trending and lifecycle management principles.
• Ensure effective governance of reference standards, critical reagents, and assay performance monitoring programs.
• PPQ, Validation & Continued Process Verification
• Partner cross-functionally with Manufacturing, MSAT, and CMC teams to ensure QC readiness for PPQ execution and commercial manufacturing.
• Provide QC oversight for in-process, release, and stability testing supporting validation campaigns and commercial supply.
• Support continued process verification (CPV) programs through statistical trending, data analysis, and ongoing monitoring of product quality attributes.
• Ensure timely and compliant batch disposition support through robust data review and issue escalation processes.
• Combination Product Quality Control Leadership
• Lead QC strategy and oversight for combination products, including pre-filled syringes, autoinjectors, and device constituent components.
• Ensure compliant testing strategies for container closure integrity, product-device compatibility, particulate matter, functionality, and device-related attributes.
• Oversee QC support for extractables and leachables (E&L), shipping validation, and stability programs associated with delivery systems.
• Ensure QC operations and external partners comply with applicable combination product regulations, including 21 CFR Part 4 and relevant global

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