About the job
As a Senior Manager of Quality Assurance in Product Development at AbbVie, you will play a pivotal role in supporting our innovative pipeline by ensuring that high-quality clinical supplies are delivered to patients in compliance with global regulatory standards. You will oversee the entire supply chain, from drug substance to finished product, while providing strategic direction and quality oversight. As part of interdisciplinary product development teams, your expertise will drive early identification and mitigation of pipeline risks through collaboration across AbbVie’s R&D functions and partnerships.
Key Responsibilities:
- Lead program oversight for the RDQA QA organization, ensuring timely communication on program strategies and management of issues.
- Act as the QA representative for CMC product development teams to facilitate timely drug approvals for clinical trials.
- Drive complex global cross-functional process improvements.
- Provide innovative, risk-based solutions to intricate technical challenges.
- Prepare for regulatory inspections and internal audits, representing Quality during these assessments.
- Draft, review, and approve exception reports, including high-impact complex ERs across multiple functions.
- Manage clinical supply product actions and recalls effectively.
- Support in-licensing and collaborative activities.
- Ensure quality agreements are established between R&D and external partners, including manufacturers and laboratories.
- Influence decision-making among R&D Directors and VPs, while mentoring staff members.

