Read from the listing itself, not guessed. “Remote” does not always mean any country, so confirm with the recruiter.
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.
Summarized by RemoteWork from the original listing. Always confirm details on the employer’s page.
Ready to apply?
Your application goes straight to Dianthus Therapeutics, on their own hiring page.
Dianthus Therapeutics develops complement antibody therapies for patients with severe autoimmune diseases. Its investors include 5AM Ventures, Fairmount, Fidelity and Venrock.
