Founded in 1997 by two Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies.

To lead the IT Quality function in meeting the standards required by our clients and regulators.

To act as subject matter expert on IT Quality processes (Computerized Systems Validation, GXP, 21 CFR part 11 etc.), striving to improve on existing IT quality processes to ensure that the IT function delivers secure, robust and compliant systems and services.

• Act as IT lead in supplier audits
• Advise on IT quality processes when required.
• Act as Liaison between IT and Business Quality functions on all aspects of quality.
• Schedule and ensure delivery of periodic reviews of computerized systems.
• Regular review of existing processes and documentation, identify gaps against requirements then author (or delegate) and implement for all processes and services.
• Operate, Review and maintain Quality processes in support of Computerized Systems Validation and qualification such as;
• o    Periodic Review
• o    Change Control
• o    Incident / Problem management
• o    IT CAPA
• Review and audit third party suppliers in line with supplier qualification and periodic review processes
• Identify and perform risk assessments on all IT infrastructure, applications and support processes, documenting and resolving any findings
• Produce monthly quality service metrics report and present to Business Quality functions as required.

o    The IT Quality Manager will report to the Director of Infrastructure and Systems.

BEHAVIOURS AND SKILLS ESSENTIAL TO ROLE:·        

• Previous experience of working within Pharmaceutical / Medical services company
• Exposure to working with Quality Management Systems, specifically GxP EU Annex 11 and/or 21 CFR part 11.
• Experience in following CSV guidelines such as GAMP5 and Data Integrity.
• Exposure to or awareness of data protection standards such as GDPR and HIPAA.
• Exposure to or awareness of quality management process such as ISO9001 and ISO27001.
• Ability to coordinate complex tasks within the IT function and business as appropriate, including developing plans, coordinating resources, resolving issues and maintaining compliance to all relevant standards and methodologies.
• Good / Strong English language skills (written and spoken)
• Proven capability in writing documentation
• A good understanding of IT technologies
• Awareness/Certification in ITIL processes.
• Proven communication skills are essential in this role.

Why Should You Apply?

• We offer a friendly professional working environment
• We offer a competitive salary plus a good benefits package
• We offer the chance to make a difference as this is the type of company where your work, your individuality and your opinion is noticed and taken into account.