About the job
As a Senior Manager in Product Development Quality Assurance at AbbVie, you will play a crucial role in supporting our innovative pipeline. Your primary responsibility will be to ensure the delivery of high-quality clinical supplies that comply with global regulatory standards, ultimately benefiting patients. You will guide and oversee the supply chain quality processes, including manufacturing, testing, and release from drug substance to final product. You will be an integral part of interdisciplinary product development teams, such as CMC teams, where you will proactively identify and mitigate pipeline risks through effective collaboration across AbbVie’s R&D functions and external partners.
Key Responsibilities:
- Provide comprehensive oversight for the RDQA QA organization, ensuring timely communication on strategies and issue resolution.
- Act as the QA representative for CMC product development teams to facilitate drug approvals for clinical trials, adhering to program timelines.
- Lead complex global cross-functional process improvement initiatives to enhance operational efficiency.
- Develop innovative, risk-based solutions to complex technical challenges in quality assurance.
- Prepare for regulatory inspections and internal audits; represent Quality during these evaluations.
- Write, review, and approve exception reports, particularly those with high impact across multiple functions.
- Manage clinical supply product actions and recalls effectively.
- Support in-licensing and collaboration efforts across various projects.
- Ensure robust quality agreements and compliance aspects are established with R&D, third-party manufacturers, laboratories, and service providers.
- Engage with R&D Directors and VPs, influencing key decisions and mentoring team members.

