The Manager, Product Quality plays a central role in maintaining the integrity of pharmaceutical, biologic, device, and combination products across AbbVie and external manufacturing locations. This position leads final quality determinations for products manufactured by third parties, ensuring alignment with global regulatory standards and business goals.
Key Responsibilities
- Acts as the primary quality authority for product batches, making final release decisions for products produced by external manufacturers.
- Leads quality oversight for projects involving internal and external teams, ensuring timely delivery, compliance, and operational efficiency.
- Contributes to the development and execution of global Product Quality Assurance strategies across diverse product types and manufacturing networks.
- Provides expert input on quality and regulatory compliance for sterile, biological, liquid, solid, and device-based products, escalating high-risk issues as needed.
- Ensures quality agreements are aligned with legal contracts and that all parties meet their commitments, supporting resolution when gaps arise.
- Builds and maintains collaborative relationships with third-party manufacturers, internal plants, and cross-functional teams to understand site-specific quality needs and risks.
- Engages with external quality teams to align expectations, reduce compliance risks, and support cost-effective operations.
- Coordinates audit planning and inspection readiness with QA teams, reviewing findings and driving corrective action timelines.
- Leads pre-approval inspection efforts for third-party sites to support timely regulatory approvals and market access.
- Supports new product launches by ensuring quality systems are in place for manufacturing, packaging, and testing at third-party and AbbVie sites.
- Oversees trend analysis for compliance data, including non-medical and medical events, and supports investigations and follow-up actions.
- Manages Corrective and Preventive Actions and exception documentation to maintain compliance and continuous improvement.
- Conducts regular management reviews with third-party partners to address quality performance, operational challenges, and organizational effectiveness.
- Reviews and evaluates Annual Product Reviews and Product Quality Reports from third-party manufacturers to ensure data accuracy, completeness, and appropriate trend response.
