Remote Associate Director, Biologics QA & Compliance

remote work; United States; À distance; USD 180 000 - 280 000; Plein temps

Résumé du poste

Dianthus Therapeutics is seeking a senior QA leader to oversee QA across development, manufacturing, and regulatory activities, guiding external manufacturing and testing partners and ensuring regulatory readiness.

You will drive cGMP compliance, lead deviations and change controls, and support regulatory submissions while managing quality relationships with CMOs and ensuring batch disposition of GMP materials.

Qualifications

• Minimum 10+ years in biotech/pharmaceutical industry with biologics.
• At least 5+ years in QA oversight.
• 5+ years managing quality relationships with CMOs and batch disposition of GMP materials.
• Strong knowledge of cGMPs, ICH Q8/Q9/Q10, EU GMP, and 21 CFR Parts 210/211.
• Experience with aseptic/sterile manufacturing and quality systems (CAPA, deviations, change control, supplier management).
• Proven project management, communication, and cross-functional collaboration skills.

Responsabilités

• Provide QA oversight of CMO/CTO operations for cell banks, drug substance, and drug product.
• Review and approve protocols, master batch records, specifications, analytical methods, and data.
• Ensure operations comply with cGMP and company policies, including EU release with QP.
• Lead deviations, investigations, OOS, change controls, and risk assessments (FMEAs).
• Support regulatory submissions and act as QA lead for submission reviews.
• Partner with CMOs/CTOs to maintain phase-appropriate quality systems and external relationships.

Connaissances

QA oversight

cGMP knowledge

ICH Q8/Q9/Q10

EU GMP

21 CFR 210/211

CAPA

Deviations

Change control

Supplier management

Project management

Cross-functional team

Communication

Formation

BS in Biology/Chemistry/Engineering or related life sciences

MS in Biology/Chemistry/Engineering or related life sciences

Description du poste

Dianthus Therapeutics is seeking a senior QA leader to oversee QA across development, manufacturing, and regulatory activities, guiding external manufacturing and testing partners and ensuring regulatory readiness.

You will drive cGMP compliance, lead deviations and change controls, and support regulatory submissions while managing quality relationships with CMOs and ensuring batch disposition of GMP materials.