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.
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.
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.
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 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).
This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectionate or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
In this role, the selected candidate will be responsible for monitoring and supporting quality systems such as laboratory investigations, deviation management, CAPAs, instrument qualifications and change management.
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.