Université Laval

University of Tübingen

Global Head Quality Intelligence & External Affairs at Novartis

Basel, Basel-city, Switzerland

Establish and drive execution of the Novartis GxP intelligence and external engagement strategy and associated priorities and initiatives. Drive external engagement in selected external associations (PDA, DIA, ISPE, EFPIA/EBE, IFPMA, etc), working groups, conferences and topics related to pharmaceutical/biopharmaceutical manufacturing science and technology, quality and GxP regulations. Global regulatory intelligence for emerging GxP regulations and Health Authority expectations. Lead teams and projects cross-functionally and cross-divisionally, e.g. on post-approval changes (ICH Q12).Build and foster relationships with internal and external stakeholders.Knowledge management, communication.

Novartis

Global Head Quality Intelligence & External Affairs

Drive external engagement in associations (PDA, DIA, ISPE, EFPIA/EBE, IFPMA), working groups, conferences and topics related to pharmaceutical/biopharmaceutical manufacturing science and technology, quality and GxP regulations. Global regulatory intelligence for emerging GxP regulations and Health Authority expectations. Lead teams and projects cross-functionally and cross-divisionally, e.g. on post-approval changes (ICH Q12).Build and foster relationships with internal and external stakeholders.Knowledge management, communication.

Head Quality Intelligence

External engagement in industry associations, working groups, conferences and topics related to pharmaceutical/biopharmaceutical manufacturing science and technology, quality and regulationsRegulatory intelligence for emerging GxP regulations and Health Authority expectations Lead teams and projects cross-functionally and cross-divisionallyBuild and foster relationships with internal and external stakeholders

Head GxP Regulations Coordination

Knowledge managementDesign, implement and optimize business process and best practicesBuild and manage relationships with key stakeholdersTalent development

Head Project Office, Global Biopharmaceutical Operations

Define CMC regulatory strategy for biologicsLead CMC submission activities worldwide (from first in man trials to market (CTD))Dossier writing and review

Project Leader, CMC Regulatory Affairs

Design and implement a quality system (ICH Q10) in a start-up biotech company; drive change to a quality culture

Ursula Busse