Quality Manager - based in Europe

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

The Quality Manager is responsible for leading the Procedures team. This team ensures that PrimeVigilance’s controlled procedures and training activities are managed in compliance with global regulations, legislation and PrimeVigilance requirements. The Quality Manager leads, educates, mentors and develops the Procedures team to ensure their competence and confidence in their assigned roles.

• Ensures support to all PrimeVigilance functional teams in developing, managing and implementing PrimeVigilance Controlled Procedures and related training.
• Manages and oversees subsystem administrators for the Quality Management Control System.
• Participates in efficiency projects to improve the use and management of the Quality Management Control System.
• Ensures access requests to PrimeVigilance Controlled Systems for employees and clients are reviewed and approved by the Procedures Management team.
• Ensures support is provided to PrimeVigilance functional teams and to the Quality Assurance team for audits and inspections by providing reports, procedures or training records from the PrimeVigilance Quality Management Control System.
• Participates, as required, in audits and inspections as a Subject Matter Expert on the PrimeVigilance Quality Management Control System and the processes for managing controlled procedures.
• Ensures support to the Quality Projects team in preparing metrics data for oversight of and reporting on PrimeVigilance’s Quality Management System

• Educated to degree standard or appropriate equivalent work experience
• Previous experience in a Quality and/or Compliance-related role
• Previous line management experience ·
• Prior experience with electronic Document Management or Training Management systems
• Desirable: Prior experience in Pharmacovigilance, Medical Information, or Medical Devices
• Knoweldge of MasterControl Document Management system

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.