Major accountabilities:

• Ensure the Quality principles, policies and procedures that foster a knowledgeable and compliant organization are engrained in routine activities of the Novartis Patient Support organization.
• Ensure quality KPIs are quantifiable with success metrics.
• Identify, develop and implement training system that addresses Quality and Compliance policies and requirements relevant to specific roles within each NPS function.
• Continuously evaluate, to identify opportunities in area of Quality/Compliance systems and standards including remedial action plans and tracks resolution.
• Periodic monitoring of internal hub and external vendors systems and processes to ensure compliance.
• Manage NPS audit & assessment programs
• Prepare periodic metric report for NPS management and highlight any areas for improvement as needed.
• Liaise with Drug Safety, Country Quality, Patient Oriented Programs (POP) owners, Legal, Privacy and Compliance
• Responsible for ensuring compliance with pharmacovigilance requirements such as Adverse Event source data verification
• NPS advocate in Country Quality risk assessment process and global procedure applicability review

Key performance indicators:

• Ensure established processes are being followed
• Continuous improvement trend in agreed upon metrics for NPS
• Ensure quality KPIs are quantifiable with success metrics

Minimum Requirements:
Work Experience:

• Professional experience in the field of Quality Assurance or related activities
• 5+ years of relevant experience within a regulated area of the pharmaceutical industry
• Ability to identify opportunities for continued improvements and drive their implementations across the organization.
• Knowledgeable on effective Quality documentation systems and training practices
• Good communication & negotiation skills
• Experience in project management, planning and organization, and audits.
• Ability to work effectively as an individual contributor and in a team structure; maintain strong cross-functional ties with key business partners.
• Good collaboration, communication and team facilitation skills
• Mastery of English, oral and written
• Willingness to travel, sometimes at short notice; travel time up to 10%

Skills:

• Pharmaceutical Regulations
• Continuous Learning.
• Able to effectively communicate with cross-functional teams and across boundries
• Dealing With Ambiguity.
• QA (Quality Assurance).
• Quality Management
• Pharmacovigilance (adverse event reporting requirements)
• Risk Management.
• Self Awareness.
• Technological Expertise.

Languages :

• English.