Associate Client Quality Manager

The Associate Client Quality Manager is primarily responsible for implementation and maintainenance of the quality system and training for the assigned project(s); and ensuring ongoing quality and compliance with support and oversight from the Associate Director of Quality/(Senior) Client Quality Manager. They ensure the project Quality Management System are being adhered to with the aim to deliver services of the highest quality which maintain compliance with global regulations and guidelines as well as PrimeVigilance and client requirements​.

Role and Responsibilities

The Associate Client Quality Manager (CQM) will implement and support oversight of all client quality and training related activities for their project(s) and ensure that the quality cycle is being actively implemented with support and oversight from the Associate Director of Quality/(Senior) Client Quality Manager. They will work closely with the Project Manager**,** the project team and the Quality Department.

Key responsibilities include:

• Act as the quality point of contact for all quality/training related activities for the client and project team
• Maintain a Quality Management Plan between the client and PrimeVigilance
• Project specific procedures:
  • Ensure all contracted activities are defined in controlled procedures
  • Manage and review all project specific procedures developed by PrimeVigilance
  • Ensure that a list of all procedures followed on the project is available
• Project specific trainings:
  • Maintain project specific training assignments
  • Review project specific training materials
  • Monitor project specific training completion in real time
  • Perform periodic project specific training assignment review
• Quality Events
  • Support Quality Event process
  • Perform Quality Event reviews
  • Manage client approval of Quality Events
  • Perform regular project Quality Event trending
• Monitor quality and compliance on an ongoing basis against KPIs
• Ensure client oversight of the quality and compliance of all activities performed by PrimeVigilance on behalf of the client by means of:
  • Constant contact between client and the CQM: ad-hoc communication as well as CQM participation in regular meetings
  • Provision of input and review of Client Operational Reports which will include performance against KPIs, as well as information on Quality Events
• Audits/inspections:
  • Ensure audit/inspection readiness for the project
  • Act as a point of contact for all audit and inspection related activities
  • May manage pre-audit activities, hosting and post audit activities, including CAPA management
• Ensure Business Continuity Planning, as well as regular testing for project specific systems
• Maintain oversight of relevant system access
• Provide relevant data for Pharmacovigilance System Master File preparation
• Ensure regular quality check of project specific regulatory reporting requirements table

Requirements

Essential:

University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent combination of education and experience.

Solid knowledge and understanding in Quality and Compliance activities within a GxP environment/ pharmacovigilance.

Excellent skills in planning, organization and communication.

English - Proficient written and verbal communication

Proficient in Microsoft Office.

Desirable:

Proven experience within a pharmacovigilance service provider environment.

Proven experience in a client facing role.

Experience in Medical information

Exposure to line management

Knowledge of Pharmacovigilance and Medical Information databases preferred.