Assoc Dir, QA

Novartis is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and to enhance the quality of life. We also seek to provide a return to shareholders that reflects our performance and to adequately reward those who invest ideas and resources in our company.

The AD, QA (e-Compliance) assists in achieving a sound and cost effective Quality Assurance for Computerized Systems, defining the appropriate standards and leading the IT/e-Compliance Team to ensure that all aspects relate to global/ regional Computerized Systems comply with the current GxP/CSV regulatory requirements and the related Corporate Quality standards to reduce Novartis business risk.

In this e-compliance role, you will be responsible for ensuring that all aspects of the defined GxP Computerized Systems during project and operation phases comply with the requirements of the Novartis Pharma Corporate Quality Manual and meet all relevant GxP regulatory requirements. The incumbent will also ensure that audit follow-up activities related to Computerized Systems are performed in time and and within acceptable quality levels according to the global processes. They will be responsible for the review, evaluation, and approval of Computerized System related quality concepts, plans and documents for projects and applications. This will include being the lead for the Holly Springs Site IT/QA/e-Compliance expert group to ensure uniform high quality deliverables and regulatory compliance for computerized systems. Responsibilities include:Ensure appropriate staffing and resource allocation of the QA/e- Compliance function during project governance, and in operations. Identify and report potential CSV compliance issues .Take pro-active ownership of cross functional CSV compliance related topics. Lead the Novartis cross-functional Holly Springs Computerized Systems Validation Committee (CSV) and coordinate approach and implementation of global CSV standards .Represent Holly Springs on CSV projects at the divisional and global level to including acting as Single Point of Contact (SPOC) for CSV related standards for the Holly Springs organization. The incumbent will define, maintain, and continuously improve the Holly Springs Site CSV standards and act as content owner for N7.xProvide leadership, direction and support and ensure adequate qualification of CSV projects. Strengthen the QA/e-Compliance community, assist and support the Division and provide training. Propose/maintain a CSV governance process to ensure alignment within the organization. Additional duties shall include: Support regulatory inspection preparation activities related to e- Compliance issues. PKI Security Officer (on call duty), with the following responsibilities; Acting on potential security breaches; Handling all password and PINs that are required for the role as strictly confidential information according to the Novartis Security Directives; Ensure access to the backup cryptographic hardware security modules in emergency situations.

Minimium Requirements:
Bachelors with 7+ years experience in quality / compliance role in a related industry. 10+ years prefered.Novartis Vaccines & Diagnotics is a new division of Novartis consisting of two businesses focusing on the development of preventive treatments and tools. Novartis Vaccines is the world's fifth largest vaccines manufacturer and second-largest of flu vaccines in the United States an equal opportunity employer.