Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
Lead the development, planning, and execution of GCP audits, including clinical sites, CROs, vendors, and internal processes.
Own regulatory inspection readiness and collaborate with cross-functional teams to ensure compliance with GCP standards.
Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for unmet medical needs. The company fosters a collaborative culture and is committed to advancing treatments for rare conditions.
Provides quality oversight of QC laboratory activities, ensuring compliance with global GxP regulations across multiple indications.
Manages GMP testing at CMOs and contract testing laboratories, including raw data review and exceptions management.
Collaborates with CMC Manufacturing, Quality Assurance, and Regulatory Affairs to align testing timelines with corporate goals.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.
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.
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.