US-NJ, Development Clinical QA Operations Associate 213859BR-MZ
Development Clinical QA Operations Associate
Global Drug Development
East Hanover, NJ
Facilities and Administration
The Development Clinical QA Operations Associate provides operational and administrative support to Oncology/Pharma Dev CQA teams. Responsible through excellent communication and organizational skills for operational and quality processes, including meeting planning, financial administration, report writing, AQWA management and systems oversight.
1. Operations meeting support for Global Head Onc Dev Clinical QA (ODQA) and Head Clinical Quality Operations (CQO). Lead operational meeting organization and planning for Global Heads
Responsible for meeting documentation, including agenda, minutes, actions and follow-up, for standing, off-site, and global team meetings, QRBs, and monthly activity reports.
2. Administration for Oncology/Pharma/CQO QA finances and budget:
Review internal costs on a monthly basis
Identify inaccuracies and variances, follow-up to assure adherence to budget targets
Track travel and other costs and report quarterly to Global Head ODQA and CQO.
3. System management support for ODQA/Pharma/GCO QA:
Support implementation of DevQA Quality Plan, track deliverables and assure owners meet implementation/deliverable deadlines
Support data gathering and compilation of information for Quality Review Boards
Generate reports from AQWA Audit and AQWA Quality Events
Support CAPA follow-up process and monitor planned and conducted audits in AQWA to ensure data quality and timely closure of open actions
Handling confidential personnel and regulatory documents
4. Inspection and audit readiness:
Responsible for health authority inspection and audit operations, including back room support, document retrieval and logistics
Support inspection and audit readiness activities, including generation and compilation of regulatory relevant documents
Collect, store and maintain all auditable documentation as per Novartis internal standards.
5. Communications and website administration:
Draft departmental memos and email communications on behalf of Global Heads; send for approval and distribute.
Maintenance of the Oncology/Pharma Dev CQA webpages and SharePoint sites. Regularly check sites for accuracy, update information, and compile new content as required.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
College degree and/or administrative school certificate preferred; High school degree is minimal requirement.
English (fluency required)
At least 5 years administrative experience, preferably in a pharmaceutical/scientific environment
Highly proficient in Microsoft Word, PowerPoint, Excel, Adobe Connect, Sharepoint, Concur, Ariba and Outlook.
Strong understanding of Novartis Organizational policies and procedures; and able to work with international colleagues
Demonstrated history of providing executive level support and interaction with all levels of management.
Capable to handle multiple tasks concurrently with tight time schedules by appropriate self-prioritization of work with minimal supervision
Ability to initiate quick follow-up actions and to perform duties with a great deal of latitude for independent judgment
Must be proactive, efficient, customer-focused and able to work under pressure with tight timelines
Strong attention to detail with good organization skills and ability to exercise independent judgment.
Able to deal with high-level contacts and exposure to sensitive information/
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.