Company Description

Medicine moves forward here. So will you. 

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.  

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. 

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. 

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you. 

Job Description

The Quality Specialist, Quality Process is responsible for ensuring that Ergomed Groups controlled procedures, GxP training activities and provision of systems’ access are managed in compliance with global regulations, legislation and Ergomed Group’s requirements. 

ROLE AND RESPONSIBILITIES
Leadership and Compliance: 

• Provide support and guidance to Ergomed colleagues and functional teams in developing, managing, and implementing Controlled Procedures. 
• Ensure GxP activities are conducted in compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO. 
• May act as the Subject Matter Expert for GxP Quality Operations and Training regulations and the Ergomed Quality Management System, providing input into procedures, policy, and training as required. 

Training and Development: 

• Assist in Driving GxP training activities across the Ergomed group, ensuring employees are adequately trained to meet global GxP requirements and client expectations, with support from the Learning and Development team. 
• Assist in ensuring GxP training is efficient and effective and that training activities are tracked to completion 
• Partner closely with Learning and Development to drive excellence in training

Quality Management System Oversight: 

• Assist in the triage and management of processes controlling access to Ergomed Group Quality Management System. 
• Participate in efficiency projects to enhance the use and management of the Ergomed Group 

Quality Management System.

• Ensure access requests to Controlled Systems for employees and clients are reviewed and approved. 

Business Continuity and Audit Support: 

• Assist in providing Business Continuity activities across the Ergomed Group. 
• Provide support to functional and Quality teams for audits and inspections by supplying reports or procedures from the Ergomed Group Quality Management System. 

Metrics and Reporting: 

• Assist in the preparation and analysis of Quality Operations and Training related metrics, providing periodic reports to management. 
• Take a role in preparing any required CAPA or Deviation records resulting from issues in the Controlled Document, GxP Training and BCP process. 

Team Leadership and Development 

• Assist in mentoring and leading the Quality Process and Training team helping to develop team members and to build competence, confidence, and subject matter expertise. 
• Foster a collaborative, high‑performing quality culture across global teams and regions. 
• Provide coaching and professional development opportunities to enhance team capability and succession planning.

Qualifications

University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or suitable experience