The Plant Quality Manager makes risk-based assessments regarding processes that may not be solely connected with compliance and has authority to determine direction and after consultation with the Plant Manager move forward to implementation.
The QA Manager is responsible for the quality management of vendors and contractors to ensure regulatory compliance of manufacturing, testing, packaging, and release activities of Contract Manufacturing Organizations (CMO's).
Responsible for coordinating and ensuring that Quality auditing of CGT CMO is carried out according to the Novartis Quality Manual - maintain the routine auditing schedule for CMOs, participate in audits if required, manage action plans and follow up on agreed upon CAPAs.
Demonstrate expert knowledge for management of investigation programs, procedures and tools, with domain knowledge of impact assessment and implication on either related areas to assure comprehensive investigations to avoid repeat of issues/incidents; reviews and trend and understands issues impacting overall organization.
Responsible for the development of direct reports by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs
This position supports the North America Quality Department through implementation of applicable regulations, compliance with FDA requirements and internal standards. This position is also responsible for maintenance and administration of Quality Document Management system while working in collaboration with the Training Group to ensure appropriate rollout.
In this role, the selected candidate will perform all technical final financial statement review in addition to performing a variety of functions including audits, tax verses book adjustments, etc for a diverse group of private clients.
Work with Business teams, Business Analysts, Application Development, Project Management, Production Support and Quality Assurance on identified areas of improvement. Provides recommendations for identified areas of quality improvement.
The Quality Engineering Manager has responsibility for development and improvement of commercial products, Production Support, SPC/SQC, Laboratory experiments, creating customer samples, and product Scale-up.