Executive Director, CMC Quality Assurance

About Us

About the Role

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 ensure 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 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.
• 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

• 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.