Associate Director/Director, Quality Assurance, CMC

Dianthus Therapeutics, Inc.

. Provide quality oversight across the development, manufacturing, and regulatory approval of Dianthus products .

Posted 11/6/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Assurance oversight within the biotech and pharmaceutical industries, focusing on cGMP compliance, quality systems management, and regulatory submissions. Proven ability to lead quality oversight for biologics and combination products while ensuring adherence to industry standards and regulations.

Highest-signal resume keywords

Quality Assurance OversightCGMP ComplianceBiologics ExperienceRegulatory SubmissionsRisk Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Systems ManagementBatch DispositionAnalytical Test ReviewDeviation ManagementCAPAChange ControlFMEASOP AuthoringAseptic Manufacturing PrinciplesDrug Development Lifecycle

Soft Skills

Project ManagementCommunication SkillsRelationship Building

Tools & Technologies

Electronic Quality Management SystemsVeeva

Industry Keywords

BiotechPharmaceuticalCMOCTOINDBLAIDEPMA21 CFREU GMP

About the role

Key responsibilities & impact

Provide quality oversight across the development, manufacturing, and regulatory approval of Dianthus products
Lead QA oversight of external manufacturing partners (CMOs) and testing partners (CTOs) across biologics and combination products
Review and approve protocols, master batch records, specifications, analytical test methods and raw data, stability reports, and method qualification/validation reports
Ensure clinical manufacturing operations comply with cGMP requirements and Dianthus policies and procedures
Disposition cell banks, drug substance, and finished drug product for clinical supply
Work with the external Qualified Person to ensure investigational product is suitable for release in the EU
Oversee label and artwork review and approval
Provide quality input to process development, technology transfer, comparability, and stability strategies
Lead deviations, investigations, OOS results, and change controls, including root-cause analysis and product impact assessment
Lead or participate in risk assessments, including design and process FMEAs
Build, implement, and maintain phase-appropriate quality systems
Monitor the regulatory landscape and update quality documents accordingly
Serve as subject matter expert on CMC quality and compliance
Build quality relationships with CMOs, CTOs, and strategic partners
Support GMP supplier audits and regulatory inspections
Support IND, BLA, IDE, and PMA regulatory submissions and lead QA submission reviews
Perform other duties as assigned

Requirements

What you’ll need

BS or MS in Biology, Chemistry, Engineering, or a related life sciences discipline
10+ years of experience in the biotech or pharmaceutical industry with large molecules/biologics, including 5+ years in Quality Assurance oversight roles
5+ years of experience developing, overseeing, and managing quality relationships with CMOs
5+ years of experience performing batch disposition of GMP materials
Experience in a pharmaceutical manufacturing environment
Strong working knowledge of cGMPs and the drug development lifecycle, including 21 CFR Parts 210 and 211, 600s (for biologics), EU GMP including Annex 1, and ICH Q8, Q9, and Q10
Experience with aseptic and sterile manufacturing principles
Strong knowledge of quality systems, including deviations, OOS, CAPA, change control, supplier management, and batch disposition
Experience authoring standard operating procedures
Experience reviewing analytical test results and associated raw data
Experience participating in formal, documented risk assessments such as FMEA
Proven project management skills
Ability to understand business needs and translate them into practical, phase-appropriate quality solutions
Excellent written and verbal communication skills
Preferred: combination product and/or medical device experience, including familiarity with 21 CFR Part 4 and 21 CFR Part 820/QMSR/ISO 13485
Preferred: 2+ years of GxP auditing experience
Preferred: experience with electronic quality management systems such as Veeva

Benefits

Comp & perks

Remote work option
Opportunity to impact investigational medicines delivered to patients
Collaboration with cross-functional teams and strategic external partners