Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Support GCP/GCLP/GVP audits for investigational sites, internal systems, and clinical service providers, including planning, coordination, and reporting.
Assist with commercial inspections, inspection readiness activities, and GCP compliance tasks such as investigations and change controls.
Maintain a continuous improvement mindset and represent the Clinical Quality Assurance Team in cross-functional projects.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer patients. The company is a clinical-stage organization with a strong focus on innovation and collaboration in a fast-paced environment.
Lead analytical development and quality control strategy for programs.
Partner with CDMO and contract labs as technical point of contact.
Perform in-depth review and interpretation of analytical data for regulatory submissions.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.
Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.