Leads the Branchburg Quality Control Laboratories and serves as integral member of the Quality leadership team. The role is accountable for ensuring compliance with all applicable regulatory and compliance requirements and must ensure the site is anticipating and building capabilities in-line with regulatory expectations and trends. Provides strategic, scientific, and operational leadership for all QC testing activities supporting the commercial manufacturing of tissue products. This role oversees laboratory functions, personnel and budget management, method validation and transfer, regulatory compliance, and continuous improvement initiatives. The Senior Manager will partner cross-functionally to maintain reliable product quality and throughput.
Responsibilities:
- Lead a team of Quality compliance professionals to manage daily operations of the QC labs (microbiology, mechanical, sterility, etc.), including personnel supervision, scheduling, and workload prioritization.
- Refine, update, and monitor the inspection readiness system that includes prior inspection/audit findings and build linkages to corporate or enterprise-level quality teams. Ensure compliance with GMP, GLP, FDA, EMA, and other applicable regulatory standards.
- Oversee validation, execution, and troubleshooting of microbiological and sterility assurance methods (bioburden, endotoxin, sterility testing, environmental monitoring, etc.) for both internal processes as well as any that are externalized to CROs.
- Build, deploy and monitor other operational, quality/compliance programs and learning and performance elements to advance the one operations and quality culture mindset maturity within the site operations sites and functions. Perform proactive compliance assessments and evaluations of relevant facility or system changes, new product implementations, risk management activities, investigations/complaints, quality plans.
- Mentor and develop quality and compliance staff within the region as part of organizational development (in partnership with site quality leaders).
- Deploy and implement relevant information / actions to the site from various regulatory, compliance, quality management, CoE, and operational or quality improvement initiatives / forums within AbbVie.