Director, Quality Control

Oruka Therapeutics•Waltham, MA

22h•$213,000 - $240,000•Hybrid

About The Position

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. 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.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline; advanced degree preferred.
10+ years of progressive Quality Control and analytical experience within GMP biopharmaceutical environments, including late-stage clinical and commercial readiness activities.
Experience overseeing GMP analytical testing for clinical-stage biologic DS and DP, including release, stability, in-process, and/or comparability testing performed by CMOs or contract testing laboratories.
Demonstrated experience supporting BLA and/or MAA submissions, regulatory inspections, and commercial launch preparation.
Deep expertise in biologics analytical methods, including chromatographic, electrophoretic, cell-based, compendial, and microbiological techniques.
Extensive experience with analytical method validation, lifecycle management, comparability, and technology transfer.
Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4.
Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
Proven success leading QC support for PPQ campaigns, validation activities, and commercial manufacturing readiness.
Demonstrated experience managing CMOs, contract laboratories, and global external testing networks.
Strong understanding of data integrity principles, electronic systems, and QC compliance requirements.
Proven ability to build and scale Quality organizations in a fast-paced biotech environment.
Excellent leadership, communication, and cross-functional collaboration skills with the ability to influence at all organizational levels.

Nice To Haves

Direct experience supporting successful BLA approval and commercial product launch.
Experience in a rapidly growing biotechnology company transitioning to commercial operations.
Knowledge of extractables/leachables, container closure systems, and device constituent testing.
Experience implementing or optimizing LIMS, stability systems, and digital QC infrastructure.
Experience supporting global regulatory filings and international commercialization activities.

Responsibilities

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.
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.
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.
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 guidance.
Support commercial readiness and lifecycle management for combination product manufacturing and release.
Provide QC oversight for analytical testing of clinical drug substance and drug product, including release, stability, in-process, characterization, and comparability testing.
Provide oversight of contract testing laboratories and CMOs, including selection, qualification, governance, performance management, and risk mitigation.
Establish and maintain Quality Agreements and analytical governance structures aligned with commercial and regulatory expectations.
Lead oversight activities during critical manufacturing campaigns, investigations, audits, and inspection preparation activities.
Drive accountability and performance across the external analytical network to ensure reliable execution and compliance.
Lead complex investigations involving OOS, OOT, deviations, laboratory events, complaints, and analytical discrepancies.
Ensure robust root cause analysis, effective CAPA implementation, and sustainable compliance solutions.
Champion data integrity principles (ALCOA+) and ensure compliance across QC systems, laboratories, and third-party partners.
Establish meaningful QC metrics, dashboards, and management review processes to drive operational excellence and continuous improvement.
Author, review, and approve QC-related sections of regulatory submissions, including analytical methods, specifications, validation reports, comparability assessments, and stability data.
Serve as the QC Subject Matter Expert during regulatory inspections, pre-approval inspections (PAIs), and partner audits.
Lead responses to health authority questions, observations, and deficiency letters related to analytical and QC activities.
Maintain current knowledge of evolving global regulatory expectations for biologics and combination products.