GPS Quality Manager

Global Patient Safety (GPS) Quality Management Manager

The Global Patient Safety (GPS) Quality Management Manager is responsible for the operational implementation of the Pharmacovigilance (PV) Quality Management System (QMS) in a consistent, effective, and efficient way within the Global Patient Safety functional area. This role also provides pharmacovigilance (PV) oversight for the management and operational maintenance of third-party contractual obligations.

• Drive the growth of the GPS Quality Management function.
• Drive & Implement the Comprehensive Training Program.
• Manage GPS Procedural Document activities.
• Actively participate in and coordinate GPS Audit & Inspection Readiness, Support & Management.
• Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development).

Roles And Responsibilities:

• GPV internal Audit program and Inspection activities:
• Coordinate and manage GVP Audit & Inspection activities
• Prepare GPS team members on inspection readiness activities
• Ensure appropriate documents are readily retrievable to use during an Inspection
• Support the coordination and preparation of GPS responses to audit & inspection findings
• Deviation & Corrective And Preventive Action (CAPA) Activities:
• Assess GPS issue management trends and develop / implement actions plans to mitigate systemic causes
• Identify internal deviations and lead GPS team in determining corrective and preventive actions
• Guide the GPS team to determine root cause of issue to avoid recurrence
• Collaborate with the argenx Quality functional area, lead the implementation of corrective or preventive actions
• Training, Procedural Document, & Record Management Activities:
• Develop and implement the Pharmacovigilance training program
• Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures
• Support document control through use of Veeva System
• Operational management and maintenance of PV contractual obligations/Pharmacovigilance Agreements (PVAs) between argenx and 3rd parties:
• Represent the GPS Team in the assessment of vendor services outside of GPS that may have an impact on Pharmacovigilance
• Manage and oversee the process of incorporating appropriate language into contractual agreements to clarify safety reporting expectations based on the scope of services provided and/or development, approval, execution, maintenance, and termination (when applicable) of PVAs
• Drive relevant planning, execution, and governance of PV contractual obligations in partnership with legal and appropriate GPS staff
• Resolve vendor questions and escalate issues to relevant GPS staff as appropriate
• GPS Performance & Compliance activities:
• Coordinate development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs
• Monitor compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff
• Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables
• Maintain the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents
• Coordinate the development and compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
• Other Activities:
• Perform other tasks and duties as assigned by line manager or GPS Leadership

Skills And Competencies

• Excellent planning and organizational skills
• Excellent oral and written communication skills
• Ability to work in global environment
• Solution oriented with ability to prioritize and work independently
• Excellent presentation skills with the ability to communicate complex issues clearly
• Demonstrated ability to author and contribute to procedural documents
• Ability to motivate, influence, and collaborate with multidisciplinary teams
• Professional level computer skills, including proficiency with tracking systems, presentation software
• Fluency in written and spoken English

Education, Experience And Qualifications

• At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience
• At least 7 years of experience in the pharmaceutical/biotech industry with at least 5 years in relevant pharmacovigilance/drug safety field
• Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams
• Road robust experience with preparing for, hosting and responding to audits and regulatory inspections globally
• Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
• Expert knowledge of GXP quality and compliance requirements, processes and measures