Senior Principal TOPI Lead

Job Description

Your key responsibilities:Your responsibilities include, but are not limited to:1. Plan, lead and implement DO Process Standards and Control (PSC) across platforms, franchises or therapeutic areas. Accountable for all quality related aspects within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved. 2. Leads discussions with internal stakeholders and partners across and outside GDD in support of quality deliverables. Leads DO and PSC towards agreed deliverables, proactively addressing potential issues before they become problematic 3. Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. 4. Actively participate in PSC Team and partners with organization to progress DO towards industry best practices, simplification, agility and deliverable effectiveness. 5. Manages and measures quality within platform, franchise or therapeutic area. 6. Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical and Qualitly functions. 7. Lead independently or participate in improvement initiatives and/or non-clinical projects. Lead/participate and keep current in Industry regulations and requirements. Ensure Novartis participation in industry regulation initiatives (i.e. ICH, GCP, etc.)8. Coordinates exception requests, deviations and corrective/preventative action plans for corresponding processes, systems and deliverables. 9. Ensure relevant SOPs/Working practices/trainings are in place with timely training and adherence cross functionally. Proactively reviews existing processes and identify opportunities for improvement 10. Represent Quality and Compliance regarding requirements and evaluation of systems that directly relate to DO or quality activities. 11. Ensures DO at Novartis is considered as industry leading internally and externally; lead, influence, collaborate and proactively shape the external environment including regulatory guidelines, industry practices and professional organizations. Serves as a mentor within the DO Quality and Compliance organization, within Data Operations and cross functionally.Minimum requirements 1. Bachelor s degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree recommended in Life Sciences, Computer Science 2. Significant relevant experience and knowledge in the Pharmaceutical or Device Industry. Expert in regards to regulatory requirements relevant to Data Management and Statistical Programming (e.g. GCP, ICH).3. At least 9 years of experience in global drug development, within the pharmaceutical or device industry 4. A demonstrated expert in Data, Programming and Process Quality, providing guidance, mentoring and support to DO Organization. 5. Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships. 6. Proven ability to proactively identify issues, recommend and implement solutionsFluent English (oral and written). Outstanding verbal and written skills.Why consider Novartis 799 million. That s how many lives our products touched in 2019. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges.Imagine what you could do at Novartis! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
globaldrugdevelopment lifesciences datamanagement processquality computerscience drugdevelopment careeropportunities regulatoryguidelines statisticalprogramming tatementsofworksow