TRD QA CGT Modality Head

Role Purpose:

Lead/manage and/or provide quality oversight in development and research functions, including clinical trial processes, medical/clinical/preclinical safety systems and procedures, product release and handover, or projects in order to ensure compliance with health authorities requirements, internal standards and a full adherence to patients’ safety, rights and well-being. Provides risk analysis and quality expertise to internal stakeholders in order to make critical decisions. Drive a culture of quality through business partnering and supporting the quality mission and strategy.

Major Accountabilities:

• Ensure establishment, maintenance and effectiveness of quality and data management systems and practices and oversee all aspects of quality, which may include GCP, PV, GLP, GMP (including medical device), IP, change and design control, training, complaints audits, quality certifications, etc.
• Proactively provide strong QA leadership to the business by ensuring considerable quality and organization awareness in research and development activities
• Lead and manage a global QA organization and/or global quality project team and contribute to and regularly monitor the implementation of the annual Quality Plan
• Ensure adherence to global and local safety and regulatory internal and health authority standards, including GCP, GLP, GMP, PV, IP
• Ensure adequate oversight of proactive quality risk management process including quality risk assessments, to ensure risks are detected and remediated, and submission/inspection readiness activities
• Establish/ lead core governance for deviation/incident management for critical or major deviations, provide regulatory guidance and drive initiatives relevant to quality oversight of internal monitoring and outsourced activities
• Support inspections preparation and facilitation and participate in audits and inspections follow -up activities including CAPA preparation
• Communicate lessons learned from deviations/incidents, audits and inspections and drive a culture of proactive, risk -based behaviour
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key Performance Indicators:

• Quality Management System for GxP up to date and implemented
• Quality oversight on global and local clinical vendor established

Work Experience:

• Audit & Inspection Management
• Quality Management Systems
• Quality Assurance
• GxP Experience
• Good Manufacturing Practices (cGMP)
• People Management
• Quality Compliance
• Drug Development
• Research
• Drug Regulatory Affairs
• Technological Expertise
• Complaints Management
• Good Laboratory Practice (GLP) Analytics
• Incident Management
• Patient Safety
• Pharmacovigilance

Languages:

• English.