Senior Principal Quality & Compliance Lead

Job Description

5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations. Job Purpose The Senior Principal Quality & Compliance Lead leads quality deliverables within platform, franchise or therapeutic area. Drives participation and inputs within Data Operations (DO), and cross functionally where applicable, in the delivery of quality data and programs, processes and documentation which satisfies regulations and aligns with industry standard methodologies for Data Management and Statistical Programming (Data Operations). Develops simple and reproducible strategies to ensure quality deliverables, and enables organization to be agile and deliver timely to drug development programs.Your key responsibilities: Your responsibilities include, but not limited to:Plan, lead and implement DO Quality & Compliance within platform, franchise or therapeutic area. Accountable for all quality related aspects within remit to ensure full compliance to all. Leads discussions with internal customers and partners across and outside GDD in support of quality deliverables. Leads DO and Q&C towards agreed deliverables, proactively addressing potential issues before they become problematic. Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. Actively participate in Q&C Team and partners with organization to progress DO towards simplification, agility and deliverable effectiveness.Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical and Quality functions. Lead independently or participate in improvement initiatives and/or non-clinical projects. Coordinates exception requests, deviations and corrective/preventative action plans for corresponding processes, systems and deliverables. Ensure relevant SOPs/Working practices/trainings are in place with timely training and adherence cross functionally. Ensures DO at Novartis is considered as industry leading internally and externally; proactively shape the external environment including regulatory guidelines, industry practices and professional organizations. EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements What you ll bring to the role: Key Performance Indicators Achieve overall goals as set each year by Global Head Data Operations, GDO.Achieve high level of quality, timeliness and customer satisfaction across Quality and Compliance activities, deliverables and support. No critical findings as result of internal inspection, routine audits or health authority inspections relating to activities/deliverables supported by DO.Effectiveness of participation in internal and external networks/initiatives.Minimum/desirable: 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, Medical Informatics or equivalent.Languages: Fluent English (oral and written). 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).At least 7 years of experience in global drug development, within the pharmaceutical or device industry.A demonstrated expert in Data, Programming and Process Quality, providing mentoring and support to DO Organization.Consistent track record to proactively identify issues, recommend and implement solutions. Why Novartis 769 million lives were touched by Novartis medicines in 2020, and while we re proud of this, we know there is so much more we could do to help improve and extend people s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
global drug developmentgene therapylife sciencesdata managementprocess qualitycomputer sciencedrug developmentproduct development