About the job
About the Role: Join our innovative team at AbbVie as a Senior Quality Manager focused on biologics regulatory submissions. You will take the lead in authoring critical sections of Module 3 of the Common Technical Document (CTD), leveraging your extensive analytical and regulatory expertise to produce high-quality documentation for global regulatory submissions. Your role will involve collaboration with cross-functional teams, including Quality Control, Quality Assurance, Regulatory Affairs, Analytical Research and Development, and Chemistry, Manufacturing, and Controls (CMC), to ensure successful submissions that support commercial approval.
Key Responsibilities:
- Lead the authoring and review process of new applications and amendments for CTD Module 3 sections S.2, S.4, S.5, and S.7 for various regulatory submissions (e.g., BLAs, MAAs, INDs, IMPDs).
- Provide in-depth subject matter expertise in analytical methods, method validation, reference standard qualification, and stability studies.
- Guarantee that submission documents are consistent, accurate, and compliant with current regulatory guidelines and AbbVie standards.
- Stay updated on regulatory developments affecting Module 3 content.
- Effectively address project challenges and assumptions by utilizing technical knowledge and available information to meet project timelines.
- Identify potential risks proactively and suggest solutions to documentation challenges.
- Facilitate cross-functional project meetings to ensure timelines and deliverables are met.
- Engage with teams to gather and interpret technical data effectively.