Oruka Therapeutics · 1 month ago
Associate Director/Director, Quality Control
Waltham, Massachusetts, United States
Full-time
Hybrid
Lead/Staff, Director/Executive
$175K/yr - $230K/yr
8+ years expOruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases. The Associate Director/Director of Quality Control will oversee quality control strategies and ensure compliance with GMP standards in a biopharmaceutical manufacturing environment focused on monoclonal antibody production.
BiotechnologyHealth CareMedical
Responsibilities
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%)
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
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
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
Qualification
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 guidelines (e.g., ICH, WHO)
Demonstrated expertise in biologics analytical methods (e.g., ELISA, CE-SDS, iCIEF, HPLC/UPLC, bioassays, cell-based assays, endotoxin testing, environmental monitoring)
Experience with data integrity assessments or remediation within an organization or at a contract organization
Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc
Experience with analytical method transfer and validation
Experience managing multiple stability studies, protocol development, stability trend analysis, OOS/OOT investigations, root cause analysis, etc
Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges
Excellent communication skills and the ability to lead cross-functional initiatives
Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously
Preferred
Experience with combination device testing (e.g., pre-filled syringes, safety pre-filled syringes, autoinjectors)
Experience with Stability/LIMS system management and implementation
Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory submissions
Benefits
Competitive salary and benefits package.
Opportunities for professional growth and development.
Company
Oruka Therapeutics
Oruka Therapeutics is advancing innovative biologics to redefine patient care standards in chronic skin diseases.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$455MKey Investors
Viking Global Investors
2025-09-17Post Ipo Equity· $180M
2024-09-03Post Ipo Equity· $275M
2024-09-03IPO
Recent News
2025-12-12
Oruka Therapeutics, Inc.
2025-11-13
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