Executive Director, CMC Quality Assurance

Role Summary

The Executive Director, CMC Quality Assurance will lead and build a comprehensive QA team to support the development, manufacturing, and regulatory approval of all Dianthus products. You will ensure global GMP and GLP compliance, collaborate with cross-functional teams, and keep the organization inspection-ready. Experience with combination product drug delivery systems and leading QA efforts is required. This role can be remote within the United States.

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 clinical studies.
• Oversee the Event and CAPA processes (deviation, complaint, issue).
• Support supplier and contract manufacturers through audits, qualification, and ongoing performance monitoring.
• Guide quality oversight of process development, technology transfer, comparability and stability strategies; approve key protocols and reports.
• Represent QA on governance forums 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 to embed quality in a phase-appropriate manner.
• Provide QA support to nonclinical studies as needed (e.g., GLP audits of toxicology protocols and reports).
• Drive continuous improvement and foster a culture of quality and accountability.
• Additional duties as identified by management.
• Travel approximately 20% for meetings, vendor audits, or regulatory inspections.

Qualifications

• BS or MS in life sciences, engineering, or related field.
• Experience in biotech/pharma including combination product development.
• Progressive QA leadership experience in biotech/pharma.
• Deep knowledge of GMP regulations and device-specific standards (e.g., 21 CFR 210, 211, 4, 820; ISO 13485/14971; ICH Q8/Q9/Q10).
• Broad knowledge of Quality Systems (deviations, OOS, CAPAs, supplier management, batch release, training).
• Proven track record supporting drug development through commercialization.
• Experience with autoinjector or similar drug delivery combination products.
• Experience in risk management processes and tools.
• Experience leading design quality activities and batch disposition of GMP clinical supply biologics/combination products.
• GLP oversight experience (preferred).
• Experience with formal risk assessments (e.g., FMEA).
• Project management experience to support planning and task completion.
• Experience in fast-paced, pre-commercial biotech environments.
• Strong leadership, communication, and collaboration skills.
• Results-oriented, decisive, flexible, and able to manage multiple projects.

Skills

• Quality Assurance leadership
• Regulatory compliance (GMP/GLP; FDA/EMA)
• Combination product quality and medical device standards
• Quality systems and CAPA management
• Process development and technology transfer quality input
• Risk management and FMEA
• Vendor and CDMO collaboration
• Regulatory submission support (IND/BLA/IDE/PMA)
• Cross-functional collaboration and governance participation

Education

• BS or MS in life sciences, engineering, or related field.

Additional Requirements

• Travel approximately 20% as required for vendor audits, meetings, and regulatory inspections.