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.
Direct the activities of the Inspectors to assure performance of their assignments and adherence to procedures to maintain Quality Control in the Receiving Inspection and Assembly areas on a daily basis.
Grow the technical expertise of your chapter within the Software Quality dimension; work closely with squads, product owners, agile coaches and stakeholders to ensure we deliver innovative products and campaigns to our users.
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 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.
Lead and support business development activities at clients, such as identification, proposal development, and other pursuit activities, while working with the appropriate KPMG resources from other service lines and industries.
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.
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).