Client Quality Manager

2 weeks ago

Bucharest, Bucureşti, Romania Ergomed Full time €60,000 - €90,000 per year
Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider 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 has become one of the global leaders in its field. We cover all therapy areas including medical device.

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.

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

Core responsibilities

  • Oversight of all project related quality activities
  • Drive project related quality improvement and providing 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
  • Ensures relevant quality KPIs are established and monitored
  • Provide quality content and analysis for project monthly reports
  • Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client's QMS are adhered to by the Project.
  • Supporting junior members of the team and possible line management responsibilities, 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 communications skills
  • Must have leadership qualities (Line Management experience is desirable)
  • Good IT skills
Additional Information

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. 

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