Manager Quality Assurance, System & Standards

Job Description Summary

The Manager, Quality Assurance role leads the overall Quality Assurance activities for Novartis Patient Support (NPS) patient support programs in designing and monitoring Quality management systems such as training and audits that will optimize compliance to Novartis requirements and applicable GxP regulations.

 

Job Description

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.

 

Skills Desired

Change Control, Continued Learning, Dealing With Ambiguity, Guideline, Product Release, Qa (Quality Assurance), Quality Management, Regulation, Risk Management, Self-Awareness, Technological Expertise