Director, QA & CMC Compliance (Biologics) - Remote

Dianthus Therapeutics Inc; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Dianthus Therapeutics is seeking an Associate Director or Director of Quality Assurance (CMC) to lead QA oversight across development, manufacturing, and regulatory approval of our biologics. This remote role reports to the Executive Director, QA and partners with CMC, Manufacturing, Regulatory Affairs, and others to ensure quality and compliance.

You will oversee external CMOs/CTOs, drive deviations, change controls, risk assessments, and inspection readiness while guiding submissions

Qualifications

• BS or MS in Life sciences required.
• 10+ years in biotech/pharma with biologics.
• 5+ years QA oversight with CMOs.
• Strong knowledge of cGMP and ICH guidelines.

Responsibilities

• Provide QA oversight of CMO/CTO operations for biologics and combinations.
• Lead deviations, investigations, OOS results, and change controls.
• Support regulatory submissions (IND, BLA, IDE, PMA) and inspections.
• Collaborate with CMC Technical Operations, Manufacturing, Regulatory Affairs.
• Ensure EU release in collaboration with QP as needed.

Skills

QA oversight

cGMP compliance

Regulatory submissions

Quality systems

Deviations & CAPA

Root cause analysis

Batch disposition

Project management

Vendor management (CMOs)

Education

Biology/ Chemistry/ Engineering degree

Tools

Veeva

Job description

Dianthus Therapeutics is seeking an Associate Director or Director of Quality Assurance (CMC) to lead QA oversight across development, manufacturing, and regulatory approval of our biologics. This remote role reports to the Executive Director, QA and partners with CMC, Manufacturing, Regulatory Affairs, and others to ensure quality and compliance.

You will oversee external CMOs/CTOs, drive deviations, change controls, risk assessments, and inspection readiness while guiding submissions