Director, Quality Management & Compliance

Ergomed is a rapidly growing  global clinical research company.  We perform clinical trials  for rare and complex diseases.

Ergomed Plc is a public company on the London stock exchange.

The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

• Performing System Audits (in-house and on-site audits; which consist of audit planning / preparation, performing an audit and writing the audit report)
• Act as a Liaison with Client’s Quality Assurance Unit/Person
• Hosting of External Audits
• Dealing with External Audit Reports – (evaluate auditors findings and responding accordingly)
• Maintaining External Audits Records/Database
• Writing and Reviewing SOPs on Quality Assurance
• SOP Co-ordination
• SOP Review for GCP Compliance
• Archiving System Audits
• Audits of Ergomed Sub-contractors in Clinical Trials Execution, such as Central Labs, Wholesale or Importation Agencies etc.
• Phase I unit Audits
• Reviewing Personnel Training Records (checking out staff training levels and documentation)
• Up-dating Staff on GCP through Training Sessions
• IT System Audits
• Pharmacovigilance System Audits

Degree qualified in a Life Science related subject

●        Demonstrated experience working in a CRO environment with a focus of GCP Quality

●        Risk-Based Quality Experience – Proven success anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainability

●        In depth knowledge of the drug development process and worldwide regulatory requirements

●        Excellent communication, management and collaboration skills

●        Demonstrated ability to lead cross-functional teams

●        Ability to handle multiple tasks to meet deadlines in a dynamic environment

●        Effective organizational, presentation, documentation and interpersonal skills

●        Effective problem solving and decision making

●        Strong customer focus

All your information will be kept confidential according to EEO guidelines.