Director, Quality Control

Oruka Therapeutics

Director of Quality Control at Oruka Therapeutics overseeing quality control for late-stage clinical development and commercialization. Leading strategic QC functions and ensuring regulatory compliance for biologics.

Posted 5/29/2026full-timeMenlo Park • California, Massachusetts • 🇺🇸 United StatesLead💰 $213,000 - $240,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Competitive salary and benefits package.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

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Hard Skills & Tools

analytical method qualificationanalytical method validationdata analysischromatographic techniqueselectrophoretic techniquescell-based techniquescompendial techniquesmicrobiological techniquesGMP analytical testingcontinuous process verification

Soft Skills

leadershipcommunicationcross-functional collaborationinfluencing skillsorganizational capabilitiesstrategic advisingoversightproblem-solvingdata integrity understandinggovernance