Executive Director, CMC Quality Assurance

Executive Director, CMC Quality Assurance

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections.

The Executive Director, CMC Quality Assurance will be responsible for leading and building a comprehensive Quality Assurance (QA) team to support the development, manufacturing, and regulatory approval of all Dianthus products.

Reporting to the VP, Head of Quality, you will execute and oversee QA processes that assure global GMP and GLP compliance as applicable to the regions where Dianthus clinical studies are executed. You will work closely with your peers in the Quality Unit, our Technical Operations and Supply Chain teams and other cross-functional teams to support biologic and device-specific global regulatory requirements are met. Your role will be integral in assuring Dianthus is inspection-ready at all times. Experience with combination product drug delivery systems and expertise in leading QA efforts is necessary to be successful in this role.

As Dianthus is a virtual company, we rely on our multitude of critical vendors for flawless GMP and GLP execution on our behalf on all activities in our Investigational Product Supply Chain (e.g. drug / device development through finished product shipment to our clinical sites). The Executive Director, QA must possess experience and skill collaborating and influencing CDMO's, laboratory, and pack / label vendors in a positive way.

This is a unique opportunity to join a rapidly growing organization and have a significant impact on our combination product development and future pipeline projects at Dianthus. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely within the United States.

Key Responsibilities

• 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 oversightprovide 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.
• Some travel (approx. 20%) is required for company meetings and support of vendor audits or regulatory inspections (e.g. in support of Sr. Director Quality Compliance as needed).

Experience