| || 227516BR |
| || Operation Manager, Global eCompliance |
| || NBS |
| || NBS QUALITY |
| || Czech Republic |
| || Prague |
| || NOV CZE |
| || Quality |
| || Full Time |
| || Regular |
| || Global eCompliance Operations Manager , Novartis, Prague, Czech Republic
Welcome to the future of medicine.
Be part of a rapidly growing, diverse and high caliber team of passionate people who strive to make a difference. Join the Novartis team in Prague and enjoy our inspiring environment. We offer a comprehensive compensation package, a wealth of opportunities for career development and an undeniably friendly culture.
Novartis is currently searching for a Global Operations Manager to work on eCompliance
Responsible for leading, managing and developing the eCompliance services through the eCompliance managed service (eCPL Hub). Through established partnership with the managed service provider and internal stakeholders, manage demand, capacity, resources and service performance while ensuring continuous monitoring & reporting of established KPIs and KQIs. Establish and manage the eCompliance processes to support harmonized and efficient operation including portfolio management, forecasting, proactive quality management (CAPAs, compliance status, supplier Quality status, etc.), relation & impact amongst eCompliance activities, internal sourcing approach, etc. Manage and maintain the Computerized System QS (Quality System) by collecting, trending and identifying process improvement opportunities and providing project / program management to deliver effectively E2E processes.
1. Drive the management of the eCompliance Hub service relating to demand, capacity, resources and services of the NBS Quality while establishing close partnership with the eCompliance Hub vendor’s management team
2. Monitor performance and delivery of services against SLA through regular re-view. Manage recurring review of KPIs and KQIs, identify improvement oppor-tunities and work with the vendor on resolution.
3. Drive the development and establishing of the eCompliance operational process framework in close collaboration with the eCompliance leadership team while ensuring that the eCompliance processes are followed through close collaboration with the eCompliance leadership team and create continuous improve-ment through regular monitoring and trending of process efficiency
4. Manage and maintain the Computerized System Quality System (QS) by identifying process improvement opportunities and manage the delivery & implementation of effective E2E processes
5. Liaise effectively with eCompliance personnel, IT, 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.
| || The ideal candidate will have:
• Degree in Information Technology, Life Sciences, Engineering; advanced degree preferred Fluency in English (oral and written), additional language(s) a plus
• A minimum of 6-7 years of relevant experience in the Pharmaceutical Industry and in particular in supplier/vendor management in regulated functions such as Quality and/or IT.
• Hands on experience in establishing and delivering operational framework. Defining operating models with close collaboration of leadership team.
• Experienced strategic driver who is able to man-age expectations and work in high-performance team
• Good knowledge of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements.
• Good understanding in the development, implementation and lifecycle management of system & services supplier management in the Pharmaceutical industry
• Profound project management skills
• Track record of successful cross-divisional/cross-functional work with complex international and multidisciplinary teams
• Ability to adjust to multiple demands, shifting priority
Novartis is an equal opportunities employer and welcome applications from all suitably qualified persons.
Novartis Global Service Center (NGSC) in Prague:
The Center, one of 5 around the world, delivers a broad variety of services to the Novartis worldwide. We have highly qualified teams in areas such as scientific and commercial services (known as Product Lifecycle Services), IT, Human Resources, Financial Reporting & Accounting, Procurement, Real Estate and Facility Services, Legal & Compliance, Finance and Communications.
Here’s some of the reasons we think you should join us:
• A job with a purpose. At Novartis, we all contribute to our mission to discover new ways to improve and extend people’s lives.
• A wealth of opportunities for career progression and working with best-in-class professionals.
• A diverse team that reflects the rich diversity of our markets. Over 55 nationalities speaking with 30+ languages, all generations, and more than 44% of female.
• Our modern and newly designed workplace is a pleasant place that reflects the need for flexible ways of working in order to bring new ideas to life.
• We live by our values; we cherish not only what we do but also how we do it. .
• Diversity & Inclusion mind-set. We aspire to move beyond stereotypes and bias to bring differences together, so we can see the world through the eyes of our patients and customers.
Our comprehensive compensation package includes:
• Competitive salary;
• Annual performance-based bonus;
• Employee recognition scheme;
• A benefits scheme above local legislation standards including pension and risk-life insurance, benefit package for health, education, culture and sport activities;
• Healthcare program that offers easy access to comprehensive health care;
• Variety of medical check-ups or consultations on-site;
• An Employee Assistance Program;
• 25 days annual leave, 4 days paid sick leave and Christmas holiday;
• Public transport allowance;
• Flexible working arrangements including Home Office;
• Support for a healthy lifestyle through the daily offering of fruit & vegetables.
We are looking forward to talking to you and sharing more about our broad range of opportunities.