Senior Manager, Quality Control

Kyverna Therapeutics

Senior Manager overseeing QC labs in remote role for autoimmune disease therapies. Develops internal QC processes and supports analytical strategies for clinical products.

Posted 7/17/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $155,000 - $175,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Control processes and analytical methods for clinical manufacturing, with a strong focus on cGMP compliance and risk management strategies. Capable of managing laboratory personnel and overseeing contract laboratories while ensuring effective communication with cross-functional teams and regulatory authorities.

Highest-signal resume keywords

Quality Control OversightCGMP Analytical RequirementsStatistical Evaluation of Analytical DataAnalytical Method ValidationCell Therapy Product Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Method TransferStatistical EvaluationFlow CytometryMolecular/PCR-Based AssaysCell-Based Potency AssaysSafety TestingGMP ProceduresRisk AssessmentTrend MonitoringCertificate of Analysis Generation

Soft Skills

Critical ThinkingProblem-SolvingStrategic ThinkingHigh Emotional IntelligenceExcellent Communication Skills

Industry Keywords

Pharmaceutical ManufacturingQuality AssuranceBiopharmaceutical ProductsATMPsClinical TrialsContract LaboratoriesLaboratory DeviationsOut of Trend EventsOut of Specification EventsRisk Based Quality Management

About the role

Key responsibilities & impact

Provide sponsor oversight of CMO QC labs in support of clinical manufacturing.
Establish internal QC processes and maintain control strategy for investigational products.
Support analytical control strategies for Kyverna’s clinical products including ownership of product specifications.
Develop and maintain Kyverna’s stability program, including establishment of trend monitoring and statistical evaluation practices.
Manage Validation/Qualification of Analytical methods as needed, to support multi-phase clinical trials.
Provide subject matter expertise in the investigation of laboratory deviations, out of trend (OOT) and out of specification (OOS) events.
Maintain Kyverna’s internal Quality Control data management and review process, and Certificate of Analysis (COA) generation.
Support Manufacturing to develop and monitor key performance indicators and risk registry to ensure effective oversight of contract/external laboratories.
Ensure QC issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
Work with functional leadership to design, implement and maintain Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
Support business development due diligence projects as needed to support analysis and assessment of internal/external laboratory capabilities.
Other duties as assigned.

Requirements

What you’ll need

Bachelor's degree in, Biology, Biochemistry, Chemical Engineering, Biotechnology.
8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience in the field of overseeing cell therapies contract labs preferred.
Experience with method transfer from Analytical Development to QC and to/from external labs.
Expertise with cGMP analytical requirements, including regulatory regulations and requirements for biopharmaceutical products and ATMPs.
Demonstrated ability to manage laboratory personnel in a GMP setting, including training, establishment of laboratory procedures, and stability program maintenance.
Experience in statistical evaluation of analytical trend data.
Deep knowledge and experience in various analytical methods employed for cell therapy products, including flow cytometry, molecular/PCR-based assays, cell-based potency assays, and safety testing.
Must be willing to travel periodically, as needed, no more than 25% of the time.
Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills.
Strategic thinking and high emotional intelligence.
Excellent interpersonal, verbal, and written communication skills.
Ability to function efficiently and independently in a changing environment.
Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.
Demonstrated capacity to think creatively when addressing complex situations.
Ability to communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities.

Benefits

Comp & perks

Bonus
Benefits
Participation in Company’s stock plan