Associate Director/Director, Quality Assurance, CMC

Dianthus Therapeutics; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

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

Education

BS in Biology/Chemistry/Engineering or related life sciences

MS in Biology/Chemistry/Engineering or related life sciences

Job description

About the role

Dianthus Therapeutics is developing novel biologics for autoimmune diseases. This role provides QA oversight across development, manufacturing, and regulatory activities, leading external manufacturing and testing partner quality efforts and ensuring regulatory readiness.

What you'll do

• 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

What they're looking for

• BS or MS in Biology, Chemistry, Engineering, or related life sciences
• 10+ years in biotech/pharmaceutical industry with biologics, 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

For applicants in Nigeria

• The listing states Remote; it does not specify a Nigeria-specific hiring region or timezone. The timezone requirement is not stated. Confirm before interviewing.
• Pay currency or range is not stated. Confirm compensation details during interview process.
• Employment type (contractor vs employee) is not specified. Confirm during discussions.
• No explicit visa or work-authorization notes are provided. Confirm eligibility if you are applying from Nigeria.