Client Quality Manager

Overview

PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We support global partners with services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our pharmaceutical and biotechnology partners, maintaining long lasting relationships and serving all therapy areas including medical devices. We invest in our staff by providing an excellent training and development platform, value employee experience, well-being and mental health, and promote a healthy work-life balance to enable high-quality client service. Come and join us in this exciting journey to make a positive impact in patients’ lives.

Job Description

The Client Quality Manager (CQM) is primarily responsible for the implementation and maintenance of the quality system and training for their assigned client projects, ensuring that the project maintains compliance with global regulations, legislation, PrimeVigilance and Client requirements. They drive quality improvement and provide quality advice.

Responsibilities

• Oversight of all project related quality activities
• Drive project related quality improvement and provide quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensure relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Work closely with Quality Management, Quality Assurance and Audit Management teams to ensure all aspects of the company and client’s QMS are adhered to by the Project
• Support junior members of the team and provide possible line management responsibilities, including involvement in training of employees on client projects

Qualifications

• Life Sciences degree
• Strong previous pharmacovigilance experience including quality and compliance experience within a GxP environment
• Good organisational skills, attention to detail and excellent communication skills
• Leadership qualities (Line Management experience is desirable)
• Good IT skills

Additional Information

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. Our people are our greatest strength, contributing to our continued success in 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

Core Values

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

We look forward to welcoming your application.