Quality Manager, Quality Assurance

About the role

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications, partnering with small to midsize biotech companies on early phase trials. The Quality Manager, Quality Assurance fosters a culture of quality within the company and acts as an ambassador for the QA department. The role is central to preparing, maintaining and running the internal and vendor audit programme, and to managing quality risk.

Key responsibilities

• Develop and maintain the internal Quality Risk Assessment methodology and a comprehensive Audit Universe.
• Lead QA activities related to procurement and vendor oversight, and set up mechanisms ensuring ongoing monitoring and compliance with laws and regulations such as EU GVP, US FDA CFRs, JMPA and ICH-E6.
• Work closely with Vendor Management and operations teams on a risk-based, compliant audit strategy.
• Coordinate and contribute to internal system and vendor audits under the company's audit plan, including pre- and post-audit activities; conduct audits or coordinate peer review and quality control where appropriate within GxP expertise.
• Deliver Quality as a Service for client-contracted services, such as planning, coordinating or conducting audits and providing GxP QA consultancy.
• Monitor compliance within the organization and feed findings back into audit strategy and plans.

Required profile

• Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences or another relevant scientific discipline, or an equivalent combination of advanced education and industry experience.
• Experience with GVP and GCP regulatory requirements, or a willingness to broaden expertise in them.
• At least 3 years of direct auditing experience in GCP (e.g. investigational sites, TMFs, vendors) and/or GVP (e.g. safety case processing and reporting).
• At least 2 years of audit program management, including developing and maintaining risk-based audit plans.

Required skills

• Organization skills and attention to detail.
• Excellent communication and facilitation skills within a global organization.
• Proactive approach and fluency in English.