Executive Director, CMC Quality Assurance

October 22

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Dianthus Therapeutics, Inc.

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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.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• Develop and execute the company’s QA strategy across drug and device development and manufacturing. • Lead and scale the QA team, including specialists in pharmaceutical and medical device quality. • Ensure compliance with FDA, EMA, and other global regulatory requirements for combination products as applicable to Dianthus clinical studies (21 CFR Part 210, 211, 4 & 820, ISO 13485, etc.). • Oversee the Event (deviation, complaint, issue) and Corrective/Preventive Action (CAPA) process. • Support the Quality Compliance Sr. Director with supplier and contract manufacturer audits, qualification, and ongoing performance monitoring. • Guide technical development quality oversight—provide quality input to process development, technology transfer, comparability and stability strategies; approve key technical protocols and reports. • Represent QA on governance forums (Change Review Board, Inventory & Operations – I&OP, CMC Team Review, Design Review Committee) and during health authority inspections as the primary product quality contact. • Support regulatory submissions (IND, BLA, IDE, PMA) and serve as QA lead on submission reviews. • Collaborate cross-functionally with Clinical, Regulatory, CMC, and Engineering teams to embed quality in a phase-appropriate manner. • Provide QA support to nonclinical studies as needed (e.g. perform GLP audit of toxicology study protocols and reports). • Drive continuous improvement initiatives and foster a culture of quality, accountability, and collaboration. • Additional duties may be identified by functional management based on current project/business objectives.

🎯 Requirements

• BS or MS degree in life sciences, engineering, or related field required. • Experience in biotech/pharma inclusive of combination product development required. • Experience of progressive QA leadership experience in biotech/pharma required. • Deep knowledge of GMP regulations and guidance’s and device-specific standards (21 CFR Part 210, 211, 4, 820, 58, ISO 13485 and 14971, ICH Q8, Q9, and Q10). • Broad knowledge of Quality Systems including deviations, OOS, CAPAs, Supplier Management, batch release, and training. • Proven track record supporting drug development through commercialization. • Experience with autoinjector or similar drug delivery combination products required. • Experience in risk management processes and tools required. • Experience in leading design quality activities. • Experience with conducting batch disposition of GMP clinical supply biologic and combination product. • Experience with overseeing GLP (non-clinical) studies to ensure quality and compliance to governing regulations (preferred). • Experience with conducting formal documented risk assessments using a variety of risk tools (e.g., FMEA). • Experience with project management processes / tools to support in meetings, assist with project planning, and facilitate completion of tasks. • Experience in pre-commercial biotech is required where the environment is fast-paced, entrepreneurial, and risk-based thinking is critical. • Strong leadership, verbal and written skills, allowing for an open and effective dialogue throughout the company. • Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company. • Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues.

🏖️ Benefits

• 20% travel for company meetings and vendor audits • Remote work within the United States