Associate Director/Director, Quality Assurance, CMC

The role

This person will provide quality oversight across the development, manufacturing, and regulatory approval of Dianthus products. They will lead QA oversight of external manufacturing and testing partners for biologics and combination products.

What you will do

• Provide QA oversight of CMO operations for cell banks, drug substance, and drug product/combination product.
• Ensure clinical manufacturing operations comply with cGMP requirements and Dianthus policies and procedures.
• Disposition cell banks, drug substance, and finished drug product for clinical supply.
• Work with external Qualified Person to ensure investigational product is suitable for release in EU.
• Provide quality oversight of label and artwork review and approval.
• Provide quality input to process development, technology transfer, comparability, and stability strategies.
• Serve as QA lead for deviations, investigations, OOS results, and change controls.
• Lead or participate in risk assessments, including design and process FMEAs.
• Partner with the Quality team to build, implement, and maintain phase-appropriate quality systems.
• Support GMP supplier audits, regulatory inspections, and regulatory submissions.

Required qualifications

• BS or MS in Biology, Chemistry, Engineering, or a related life sciences discipline.
• 10+ years of experience in the biotech or pharmaceutical industry with large molecules/biologics.
• 5+ years in Quality Assurance oversight roles.
• 5+ years of experience developing, overseeing, and managing quality relationships with CMOs.
• 5+ years of experience performing batch disposition of GMP materials.
• Experience pharmaceutical manufacturing environment.
• Strong working knowledge of cGMPs and the drug development lifecycle, including 21 CFR Parts 210 and 211, 600s (for biologics), EU GMP (including Annex 1), and ICH Q8, Q9, and Q10.
• Experience with aseptic and sterile manufacturing principles.
• Strong knowledge of quality systems, including deviations, OOS, CAPA, change control, supplier management, and batch disposition.
• Experience authoring standard operating procedures.
• Experience reviewing analytical test results and associated raw data.
• Experience participating in formal, documented risk assessments (e.g., FMEA).

Nice to have

• Combination product and/or medical device experience, including familiarity with 21 CFR Part 4 and 21 CFR Part 820 (QMSR)/ISO 13485.
• 2+ years of GxP auditing experience.
• Experience with electronic quality management systems (Veeva)

About the company

Dianthus Therapeutics is developing potentially best-in-class therapies for patients living with severe autoimmune diseases. Their lead antibody and clinical candidates target specific disease pathology to enable convenient self-administered subcutaneous injections.