Work as Senior eCompliance Manager at Novartis | B.Pharm, B.Sc
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Sr eCompliance Manager–Supplier Quality
Manage the eCompliance/Quality aspects of GxP system and service suppliers. En-sure that the Novartis computer system validation (CSV) strategy is effectively im-plemented for suppliers of GxP systems and services, and that they remain com-pliant throughout their contract life-cycle. Drive the development of compliance standards (e.g. Global Operating Procedures, templates, and training materials) related to the Supplier management domain in collaboration with the applicable Novartis functions (e.g.: IT, Procurement, etc.). Ensure their implementation in the respective functions (e.g.: IT).
1. Drive the development and implementation of the Novartis eCompliance strategy and “OneCSV” process for Supplier management to ensure effective and compliant quality oversight over Novartis GxP computerized system & service providers.
2. Actively lead the eCompliance Supplier management activities in the organization. Develop and integrate appropriate risk based models for GxP system & service supplier management.
3. Liaise effectively with NBS IT, eCompliance personnel across NVS (e.g. manufacturing sites and countries), other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computerized systems & services are in place, maintained and opportunities for continuous improvement identified and implemented. Ensure IT procedures and tools (e.g. ICE Methodology, IGM framework) accurately integrate and align with eCompliance and GxP related requirements of Supplier management.
4. Ensure the development of and provide Global oversight over adequate qualification & life-cycle management to IT-related vendor selection, risk-based qualification and management processes and systems.
5. Drive the development and delivery of training relevant for eCPL Supplier management while cooperating with GxP Training. Lead the risk based audit strategy in collaboration with Global Quality Audit to plan and support supplier audits and audit observations related to GxP computerized systems & services to ensure gaps are identified and adequately ad-dressed.
6. Lead the development and implementation of external compliance intelligence processes to ensure that new compliance and regulatory requirements relating to supplier management of GxP computerized systems & services are proactively identified, and internal processes and systems continuously improved to reflect the latest Health Authority requirements and expectations. Identify the state of the art benchmarks through well-established industry contacts. Ensure input into the Novartis Quality Manual trigger process. Provide expert input into related Quality Modules and Directives.
• Degree in Life Sciences, Pharmacy, Engineering or Information Technology; advanced degree preferred Fluency in English (oral and written), additional language(s) a plus
• A minimum of 10 years of relevant experience (in Supplier Quality management) in the Pharmaceutical Industry and in particular in supplier management in regulated functions such as Quality and/or IT.
• Extensive knowledge of Regulatory and Quality requirements in the area of CSV. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements.
• Profound experience in the development, implementation and lifecycle management of system & services supplier management in the Pharmaceutical Development, Manufacturing and Quality space (e.g. supplier evaluation, on-going supplier quality performance assessment, conduction of quality improvement plans, etc.) Track record of successful cross-divisional/cross-functional work with complex international and multidisciplinary teams.Proven ability to adjust to multiple demands, shifting priorities.
Experience : 5+ years
Qualification : B.Pharm, B.Sc, B.E
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 30th January, 2020
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