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.
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).
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.
The ideal candidate will perform a variety of functions including performing audits, financial statement prep and technical review, tax verses book adjustments, etc for a diverse group of private clients, primarily in real estate.
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.
This position encompasses the execution and delivery a best-in-class program of quality assurance. The individual will play a key role in influencing positive change throughout the audit department globally and will participate on other special projects, as applicable.
Assure all IR-relevant systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
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.