Resumen
You will play a pivotal role in managing external service providers supporting Novartis Global Clinical Trials in R&D Quality, ensuring that our partners meet the highest standards of excellence.
About the Role
Deadline for applications: 10th of March 2025
Major Accountabilities:
- Responsible for review and approval of External Service Providers (ESP) qualification for global clinical trials.
- Responsible for negotiation and execution Quality Assurance Agreements (QAA) / quality terms with ESPs.
- Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP in a proactive manner. Ensure communication and support mitigation of actions for potential risks.
- Responsible for review and approval of quality issues related to ESPs and ensure appropriate escalation of major and critical issues. Support assessment of serious breach and reporting to health authorities.
- Collaboration with business partners such as, Vendor Partnership and Governance, Global Medical Affairs, other applicable Vendor Business Offices and Procurement to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions.
- Review quality metrics, monitoring and reporting including follow-up with line functions and escalation.
- Ensure inspection readiness of ESP related activities and support for internal and external audits and health authority (HA) inspections pertaining ESP management.
- Ensure compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes within area of responsibility.
Obligatory requirements:
- Education: Minimum a bachelor’s degree in Life Sciences, Pharmacy or Medicine, or other related discipline required
- 12+ years’ experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes and vendor management related activities is preferred.
- Good knowledge of GCP/GLP, GMP, GVP.
- Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area.
- Experience in managing External Service Providers and knowledge of quality standards and regulatory requirements. Experience in interactive response technology (IRT), eCOA and Imaging services is added advantage.
- Thorough technical understanding of quality system, clinical trial process collecting, analyzing, and monitoring of Third-party Key Quality Indicators.
- Experience in data analysis and trending using available tools.
- Demonstrated effective management and establishment of successful international and cross-divisional collaborations.
- Fluent English, written and spoken
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
