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. Responsible for executing QA processes that ensure global GMP and GLP compliance, collaborating with Quality Unit, Technical Operations, Supply Chain, and cross-functional teams to meet biologic and device-specific regulatory requirements, and ensuring inspection-readiness. Experience with combination product drug delivery systems and leading QA efforts is required. Remote work within the United States is possible.

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 (21 CFR Part 210, 211, 4 & 820, ISO 13485, etc.).
• Oversee the Event (deviation, complaint, issue) and CAPA processes.
• Support the Quality Compliance Sr. Director with supplier and contract manufacturer audits, qualification, and ongoing performance monitoring.
• Guide technical development quality oversight—provide input to process development, technology transfer, comparability and stability strategies; approve key technical 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 study protocols and reports).
• Drive continuous improvement and foster a culture of quality, accountability, and collaboration.
• Additional duties as identified by management.
• Some travel (approx. 20%) for meetings, vendor audits, or regulatory inspections.

Qualifications

• BS or MS degree 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 (21 CFR Part 210, 211, 4, 820, 58, ISO 13485 and 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 in leading design quality activities.
• Experience with batch disposition of GMP clinical supply biologic and combination product.
• Experience with overseeing GLP non-clinical studies (preferred).
• Experience with formal risk assessments using tools (e.g., FMEA).
• Experience with project management processes/tools for planning and task completion.
• Experience in pre-commercial biotech in fast-paced, entrepreneurial environments.
• Strong leadership and communication skills; ability to influence across the organization.
• Results-oriented, decisive, flexible, with the ability to manage multiple projects.
• Forward-thinking mindset and issue-resolution capability.