EDO Supplier Lead

320002BR
May 27, 2021
China

Job Description

500+ Ongoing clinical trials; 160+ Projects in clinical development; 80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:

Accountable to the CTT and other line functions within GDD in related processes and activities of identification, qualification, selection and study set up for Suppliers.

• Collaborate with the EDO Relationship Leads to support supplier governance and oversight for qualified suppliers through documented performance and issue management.
• Accountable to the CTT in the process of study set up activities of suppliers (e.g. completing the Study Specification Worksheets (SSW), providing templates for request for proposal, and providing input to supplier selection documents).
• Drive timelines and deliverable management of all external activities from identification of supplier needs to global set up of suppliers. Depending on outsourced service, perform testing and validation (User Acceptance Testing) to ensure final system programming meet service requirements.
• Evaluate, document, track and manage performance and oversight of Suppliers with input from CTTs, using appropriate tools. Accountable to the CTT to ensure changes to protocol, allocation or other study designs are consistently shared and incorporated into supplier budgets, timelines, and specifications.
• Intervene and accountable to the CTTs in Supplier issue management. Escalate issues that could present a risk to the patient safety, validity/integrity of data, regulatory acceptance and/or to Novartis business reputation in timely manner in accordance to relevant procedures.
• Responsible for ensuring supplier compliance with NVS SOPs and business guidance. Responsible, in partnership with QA, to document trial level deviations and perform Root Cause Analysis (RCA) and CAPAs as appropriate.
• Support the development and implementation of process changes and standards to continuously improve and optimize interaction by assessing trends, quality issues, and contract issues driving suppliers’ quality improvement.
• Participate in CTT meetings when required to provide overview and update on supplier deliverables. As required create appropriate training for CTT members and Suppliers for CTT Kick Off. Acountable to ensure proper and complete supplier related activities and documentations are managed to allow timely global supplier set up.

Minimum Requirements

What you’ll bring to the job:
• Bachelor’s degree required; Relevant advanced degree (MBA, Pharm.D, MD or PhD preferred)
• English: fluent written and spoken

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
Global Drug Development
GDO GDD
China
Shanghai
Research & Development
Full Time
Regular
No
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320002BR

EDO Supplier Lead

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