Associate Director/Director, Quality Assurance, CMC

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🔥 5 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 14%

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

📋 Description

• 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

• 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

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

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