US-NJ, US NCQ Development QA Associate Director 220433BR_1503420029-MZ
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Novartis is hiring an Associate Director to join US NCQ (Novartis Country Quality) Development QA function to work in partnership with the US clinical and medical departments (including Gen- Med, Oncology, DS&E, Drug Regulatory Affairs and Medical Affairs) to drive oversight of quality and compliance of US Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV), as well as GxP activities related to Marketing (e.g. HE/OR, POPs etc.). Responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight though the implementation of the Novartis Quality Manual and Quality Management System in the NCQ to ensure the business meets Novartis and Regulatory standards of quality and compliance.
1. Lead, facilitate, implement and maintain the local Quality System in the areas within scope, in accordance with the Novartis Quality Manual, the NCQ Quality Plan, and the local regulatory requirements through:
a. Driving the implementation of global quality documents
b. Authoring and together with the BU defining content of the NCQ Quality Plan, drive implementation and follow-up
c. Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA). Drive completion and implementation of CAPAs related to the Quality Risk Assessment
d. Drive completion of the Annual Management Quality Report
e. Contribute to the development of an effective NCQ risk-based audit frequency program
2. In cooperation with local DRA and DS&E, keep abreast of regulatory requirements. Drive quality related issues and provide interpretation of GCP/GPv regulations and company standards, guidelines, policies and procedures to Clinical Operations (ICRO, GMO), MA and Pharmacovigilance associates.
3. Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership with personnel, Development Line Functions and Development QA groups.
4. Represent QA in interactions with internal and external contacts and Health Authorities, as appropriate.
5. Ensure NCQ readiness for GCP and GPvP regulatory inspections by preparing line function teams for FDA HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspection.
6. Facilitate and/or lead HA inspections of the NCQ, investigational sites or external service providers. Ensure responses to local Health Authorities have been submitted, commitments have been met and relevant CAPAs have been completed/closed in AQWA in due time.
7. Lead, conduct and follow-up of GCP and Pharmacovigilance related audits at the NCQ, at vendors and at investigator sites. Coordinate answers of the auditees, together with line functions determine country observations root causes and ensure that appropriate corrective and preventive actions are implemented on all major and critical audit findings.
8. Report monthly Key Quality Indicators (KQIs) within scope of responsibilities, monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
9. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course.
10. Conduct ESP (External Service Providers) assessment and/or qualification visits for locally outsourced clinical development, MA and pharmacovigilance (PV) activities. Ensure the ESP selection and management processes are properly followed at the NCQ.
11. Ensure oversight of POP (Patient Oriented Programs) activities in the NCQ and pro-vide guidance to MPOs (Marketing Program Owners) according to current SOP.
12. Ensure that line-function heads implement appropriate training plans for their associates performing GCP/PV related activities.
13. Define the GCP elements and content of the annual self-inspection plan. Assist in the preparation, conduct and follow-up of self-inspection activities in the areas of scope according to the approved self-inspection plan.
Education: BSN, BA or BS degree in Life Sciences or related fields
Language: English fluent in speaking and writing.
• A minimum of 10 years of clinical research experience in the pharmaceutical industry. Experience in quality assurance, clinical development, field monitoring or auditing is a plus.
• Must be proficient of GCP, ICH and FDA regulatory requirements.
• Familiar with CAPA and Root Cause Analysis process.
• Effective oral and written communication skills are a must.
• Ability to lead project workstreams, work both independently and collaboratively on project teams.
• Must be flexible, dynamic and willing to adapt in a fast paced environment.
• The ability to travel up to 20% is required.
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