GPS Quality Manager

argenx

7d•$128,000 - $176,000•Remote

About The Position

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. Additionally, the role will provide pharmacovigilance (PV) oversight for the management and operational maintenance of third-party contractual obligations. This position will also drive the growth of the GPS Quality Management function, implement the Comprehensive Training Program, manage GPS Procedural Document activities, and actively participate in and coordinate GPS Audit & Inspection Readiness, Support & Management, and drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development).

Requirements

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
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.
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.

Responsibilities

Coordinate and manage GVP Audit & Inspection activities.
Actively engage in internal global GVP audit program and inspection readiness activities in collaboration with the argenx Quality functional area.
Prepare GPS team members on inspection readiness activities.
Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available).
Support the coordination and preparation of GPS responses to audit & inspection findings.
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.
In collaboration with the argenx Quality functional area, lead the implementation of corrective or preventive actions.
Develop and implement the Pharmacovigilance training program.
Develop, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc).
Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization.
Coordinate the monitoring, maintaining, re-evaluating and updating the GPS training curricula.
Provide training to relevant argenx employees and 3rd parties (when applicable).
Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS processes & procedures.
Proactively engage in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided.
Support document control through use of Veeva System.
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.
In collaboration with relevant GPS stakeholders: Drive relevant planning, execution, and governance of PV contractual obligations in partnership with legal and appropriate GPS staff.
Act as responsible for alignment with Business Development, and participate in due diligence efforts.
Resolve vendor questions and escalate issues to relevant GPS staff as appropriate.
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.
Monitor 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.
Perform other tasks and duties as assigned by line manager or GPS Leadership.