Sr Principal Process and Training 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.Your key responsibilities:Your responsibilities include, but not limited to: 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. Leads discussions with internal team members 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. Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. Actively participate in PSC Team and partners with organization to progress DO towards industry standard methodologies, simplification, agility and deliverable effectiveness. Manages and measures quality within platform, franchise or therapeutic area. Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical and Quality functions. Lead/participate and keep current in Industry regulations and requirements. Ensure Novartis participation in industry regulation initiatives (i.e., ICH, GCP, etc.). Ensures DO at Novartis is considered as industry leading internally and externally. 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: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. Significant experience and knowledge in the Pharmaceutical or Device Industry. Expert in regard to regulatory requirements relevant to Data Management and Statistical Programming (e.g., GCP, ICH). At least 9 years of experience in global drug development, within the pharmaceutical or device industry. Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships. Outstanding verbal and written skills. Proven 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 :
trainingcustomer servicecustomer relationscalibrationcoachingglobal drug developmentgene therapylife sciencesdata managementcomputer sciencedrug development